Skip to Content

Notice

Food and Drug Adminstration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 009

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled “Modifications of the List of Recognized Standards, Recognition List Number: 009” (Recognition List Number: 009), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES:

Submit written or electronic comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document.

ADDRESSES:

Submit written requests for single copies on a 3.5′′ diskette of “Modification to the List of Recognized Standards, Recognition List Number: 009” to the Division of Small Manufacturers Assistance, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-443-8818. Submit written comments concerning this document or to recommend additional standards for recognition to the contact person (see FOR FURTHER INFORMATION CONTACT). Submit electronic comments by e-mail: standards@cdrh.fda.gov. This document may also be accessed on FDA's Internet site at http://www.fda.gov/​cdrh/​fedregin.htm l. See section VI of this document for electronic access to the searchable database for the current list of “FDA Recognized Consensus Standards,” including Recognition List Number: 009 modifications and other standards related information.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Carol L. Herman, Center for Devices and Radiological Health (CDRH) (HFZ-84), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4766, ext.156.

End Further Info

I. Background

Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards, developed by international and national organizations, for use in satisfying portions of device premarket review submissions or other requirements.

In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of guidance entitled “Recognition and Use of Consensus Standards.” This notice described how FDA will implement its standard recognition program and provided the initial list of recognized standards.

In Federal Register notices published on October 16, 1998 (63 FR 55617), July 12, 1999 (64 FR 37546), November 15, 2000 (65 FR 69022), May 7, 2001 (66 FR 23032), January 14, 2002 (67 FR 1774), October 2, 2002 (67 FR 61893), and April 28, 2003 (68 FR 22391), FDA modified its initial list of recognized standards. These notices described the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains “hypertext markup language (HTML)” and “portable document format (PDF)” versions of the list of “FDA Recognized Consensus Standards.” Both versions are publicly accessible at the agency's Internet site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List Number: 009

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will Start Printed Page 10713incorporate these modifications in the list of “FDA Recognized Consensus Standards” in the agency's searchable database. FDA will use the term “Recognition List Number: 009” to identify these current modifications.

In the following table, FDA describes modifications that involve: (1) The withdrawal of standards and their replacement by others, (2) the correction of errors made by FDA in listing previously recognized standards, and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.

In section III of this document, FDA lists modifications the agency is making that involve the initial addition of standards not previously recognized by FDA.

A. Biocompatibility

Old Item No.StandardChangeReplacement Item No.
36ASTM F1408-02e1, Standard Practice for Subcutaneous Screening Test for Implant MaterialsWithdrawn and replaced with newer version.71
16ASTM F1439-02, Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant MaterialsWithdrawn and replaced with newer version.72
65ASTM F2065-00e1, Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid MaterialsWithdrawn and replaced with newer version.73
58USP 26-NF 21 <87>, Biological Reactivity Test, In Vitro—Direct Contact TestWithdrawn and replaced with newer version.74
59USP 26-NF 21 <87>, Biological Reactivity Test, In Vitro—Elution TestWithdrawn and replaced with newer version.75
60USP 26-NF 21<88>, Biological Reactivity Tests, In Vivo—Procedure—Preparation of SampleWithdrawn and replaced with newer version.76
61USP 26-NF 21<88>, Biological Reactivity Test, In Vivo—Intracutaneous TestWithdrawn and replaced with newer version.77
62USP 26-NF 21<88>, Biological Reactivity Tests, In Vivo—Systemic Injection TestWithdrawn and replaced with newer version78

B. Dental/ENT

Old Item No.StandardChangeReplacement Item No.
46ANSI/ADA Specification No. 14:1998, Dental Base Metal Casting AlloysWithdrawn and replaced with newer version; Contact person94
49ANSI/ADA Specification No. 17:1999, Denture Base Temporary Relining ResinWithdrawn and replaced with newer version.95
53ANSI/ADA Specification No. 30:2002, Dental Zinc Oxide-Eugenol and Zinc Oxide Non-Eugenol CementsWithdrawn and replaced with newer version.96
56ANSI/ADA Specification No. 57:2000, Endodontic Sealing MaterialsWithdrawn and replaced with newer version.97
60ANSI/ADA Specification No. 96:2000, Dental Water-Based CementsWithdrawn and replaced with newer version.98
66ISO 4049:2000, Dentistry—Polymer-Based Filling, Restorative and Luting MaterialsWithdrawn and replaced with newer version.99
71ISO 6876:2001, Dental Root Canal Sealing MaterialsWithdrawn and replaced with newer version.100
77ISO 8891:1998, Dental Casting Alloys with Noble Metal Content of At Least 25% but less than 75%Withdrawn and replaced with newer version; Contact person101
79ISO 9693, Metal-Ceramic Dental Restorative SystemsWithdrawn and replaced with newer version; Contact person102

C. General Hospital/General Plastic Surgery

Start Printed Page 10714
Old Item No.StandardChangeReplacement Item No.
82USP 26, Nonabsorbable Surgical SuturesWithdrawn and replaced with newer version97
88USP 26 <11>, Sterile Sodium Chloride for IrrigationWithdrawn and replaced with newer version98
89USP 26, Absorbable Surgical SuturesWithdrawn and replaced with newer version99
90USP 26 <881>, Tensile StrengthWithdrawn and replaced with newer version100
91USP 26 <861>, Sutures—DiameterWithdrawn and replaced with newer version101
92USP 26<871>, Sutures Needle AttachmentWithdrawn and replaced with newer version102
93USP 26, Sterile Water for IrrigationWithdrawn and replaced with newer version103
94USP 26, Heparin Lock Flush SolutionWithdrawn and replaced with newer version104
95USP 26, Sodium Chloride InjectionWithdrawn and replaced with newer version105
33ASTM D3772-01, Standard Specification for Rubber Finger CotsWithdrawn and replaced with newer version106
5ASTM F882-84 (2002), Standard Performance and Safety Specification for Cryosurgical Medical InstrumentationWithdrawn and replaced with newer version107

D. In Vitro Diagnostic

Old Item No.StandardChangeReplacement Item No.
14NCCLS C24-A2 Statistical Quality Control for Quantitative Measurements: Principles and Definitions: Approved Guideline—Second EditionWithdrawn and replaced with newer version85
17NCCLS C29-A2 Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard—Second EditionWithdrawn and replaced with newer version86
19NCCLS C31-A2 Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection and Handling: Approved Guideline—Second EditionWithdrawn and replaced with newer version87
2NCCLS EP09-A2 Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Second EditionWithdrawn and replaced with newer version92
66NCCLS EP10-A2 Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline—Second EditionWithdrawn and replaced with newer version93

E. Materials

Old Item No.StandardChangeReplacement Item No.
1ASTM F67-00, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50550, UNS R50700)Update “Process(es) Impacted” to include Design Controls.1
Start Printed Page 10715
2ASTM F75-01, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)Update “Process(es) Impacted” to include Design Controls.2
3ASTM F90-01, Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)Update “Process(es) Impacted” to include Design Controls.3
5ASTM F138-00, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)Update “Process(es) Impacted” to include Design Controls.5
6ASTM F139-00, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)Update “Process(es) Impacted” to include Design Controls.6
7ASTM F560-98, Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)Update “Process(es) Impacted” to include Design Controls.7
9ASTM F563-00, Standard Specification for Wrought Cobalt-20 Nickel-20 Chromium-3.5 Molybdenum-3.5 Tungsten-5 Iron Alloy for Surgical Implant Applications (UNS R30563)Update “Process(es) Impacted” to include Design Controls.9
10ASTM 603-00, Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant ApplicationUpdate “Process(es) Impacted” to include Design Controls.10
11ASTM 620-00, Standard Specification for Titanium-6 Aluminum-4 Vanadium ELI Alloy Forgings for Surgical Implants (UNS R56401)Update “Process(es ) Impacted” to include Design Controls.11
13ASTM F648-00, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsUpdate “Process(es) Impacted” to include Design Controls.13
14ASTM 688-00, Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical ImplantsUpdate “Process(es) Impacted” to include Design Controls.14
15ASTM F745-00, Standard Specification for 18 Chromium-12.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsUpdate “Process(es) Impacted” to include Design Controls.15
16ASTM F746-87 (1999), Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsUpdate “Process(es) Impacted” to include Design Controls.16
19ASTM F961-96, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)Update “Process(es) Impacted” to include Design Controls.19
21ASTM F1088-87(1992)e1, Standard Specification for Beta-Tricalcium Phosphate for Surgical ImplantationUpdate “Process(es) Impacted” to include Design Controls.21
25ASTM F1295-01, Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant ApplicationsUpdate “Process(es) Impacted” to include Design Controls.25
26ASTM F1314-01, Standard Specification for Wrought Nitrogen Strengthened-22 Chromium-12.5 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical ImplantsUpdate “Process(es) Impacted” to include Design Controls.26
27ASTM F1341-99, Standard Specification for Unalloyed Titanium Wire for Surgical Implant ApplicationsUpdate “Process(es) Impacted” to include Design Controls.27
30ASTM F1537-00, Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical ImplantsUpdate “Process(es) Impacted” to include Design Controls.30
Start Printed Page 10716
32ASTM F1586-02, Standard Specification for Wrought Nitrogen Strengthened-21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical ImplantsUpdate “Process(es) Impacted” to include Design Controls.32
33ASTM F1609-95, Standard Specification for Calcium Phosphate Coatings for Implantable MaterialsUpdate “Process(es) Impacted” to include Design Controls.33
34ASTM F1659-95, Standard Test Method for Bending and Shear Testing of Calcium Phosphate Coatings on Solid Metallic SubstratesUpdate “Process(es) Impacted” to include Design Controls.34
35ASTM F1713-96, Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant ApplicationsClarification of Extent of Recognition; Update “Process(es) Impacted” to include Design Controls.35
36ASTM F1801-97, Standard Practice for Corrosion Fatigue Testing of Metallic Implant MaterialsUpdate “Process(es) Impacted” to include Design Controls.36
37ASTM F1813-01, Standard Specification for Wrought Titanium—12 Molybdenum-6 Zirconium-2 Iron Alloy for Surgical Implant (UNS R58120)Clarification of Extent of Recognition; Update “Process(es) Impacted” to include Design Controls.37
38ASTM F2005-00, Standard Terminology for Nickel-Titanium Shape Memory AlloysUpdate “Process(es) Impacted” to include Design Controls.38
39ASTM F2052-00, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Passive Implants in the Magnetic Resonance EnvironmentUpdate “Process(es) Impacted” to include Design Controls.39
40ASTM F2063-00, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical ImplantsCardiovascular contact person. Clarification to Extent of Recognition with regard to biocompatibility requirements.40
41ASTM F2066-01, Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)Cardiovascular contact person; Clarification to Extent of Recognition41
43ASTM F2146-01, Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)Cardiovascular contact person; Clarification to Extent of Recognition43
44ASTM F136-02, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)Update “Process(es) Impacted” to include Design Controls.44
45ASTM F562-02, Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)Update “Process(es) Impacted” to include Design Controls.45
46ASTM F621-02, Standard Specification for Stainless Steel Forgings for Surgical ImplantsUpdate “Process(es) Impacted” to include Design Controls46
47ASTM F799-02, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)Update “Process(es) Impacted” to include Design Controls.47
48ASTM F899-02, Standard Specification for Stainless Steel for Surgical InstrumentsUpdate “Process(es) Impacted” to include Design Controls.48
49ASTM F1058-02, Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008)Update “Process(es) Impacted” to include Design Controls.49
50ASTM F1091-02, Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)Update “Process(es) Impacted” to include Design Controls.50
Start Printed Page 10717
51ASTM 1108-02, Standard Specification for Titanium -6Aluminum -4Vanadium Alloy Castings for Surgical Implants (UNS R56406)Update “Process(es) Impacted” to include Design Controls.51
52ASTM F1350-02, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)Update “Process(es) Impacted” to include Design Controls.52
53ASTM F1472-02, Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400)Update “Process(es) Impacted” to include Design Controls.53
54ASTM F1580-01, Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical ImplantsUpdate “Process(es) Impacted” to include Design Controls.54
55ASTM F2182-02, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance ImagingUpdate “Process(es) Impacted” to include Design Controls.55
Dental 30 Ortho 62ISO 5832-1:1997, Implants for Surgery—Metallic Materials—Part 1: Wrought stainless steelTransferred from dental/ENT and orthopaedics.56
Dental 31 Ortho 117ISO 5832-2:1999, Implants for Surgery—Metallic Materials—Part 2: Unalloyed TitaniumTransferred from dental/ENT and orthopaedics.57
Dental 32 Ortho 64ISO 5832-3:1996, Implants for Surgery—Metallic Materials—Part 3: Wrought titanium 6-aluminium 4-vanadium alloyTransferred from dental/ENT and orthopaedics.58
Dental 33 Ortho 65ISO 5382-4:1996, Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloyTransferred from dental/ENT and orthopaedics.59
Dental 34 Ortho 66ISO 5832-5:1993, Implants for Surgery—Metallic Materials—Part 5: Wrought cobalt-chromium-tungsten-nickel alloyTransferred from dental/ENT and orthopaedics.60
Dental 35 Ortho 67ISO 5832-6:1997, Implants for Surgery—Metallic Materials—Part 6: Wrought cobalt-nickel-chromium-molybdenum alloyTransferred from dental/ENT and orthopaedics.61
Dental 36 Ortho 118ISO 5832-9: 1992, Implants for Surgery—Metallic Materials—Part 9: Wrought high nitrogen stainless steelTransferred from dental/ENT and orthopaedics.62
Dental 38 Ortho 70ISO 5832-11: 1994, Implants for Surgery—Metallic Materials—Part 11: Wrought titanium 6-aluminium 7-niobium alloyTransferred from dental/ENT and orthopaedics.63
Dental 39 Ortho 71ISO 5832-12: 1996, Implants for Surgery—Metallic Materials—Part 12: Wrought cobalt-chromium-molybdenum alloyTransferred from dental/ENT and orthopaedics.64
Ortho 119ISO 5834-2: 1998, Implants for Surgery—Ultra-High-Molecular-Weight Polyethylene—Part 2: Moulded FormsTransferred from orthopaedics.65
Ortho 76ISO 6474:1994, Implants for Surgery—Ceramic materials based on high purity aluminaTransferred from orthopaedics.66
Ortho 143ISO 7153-1:1991/Amd 1:1999, Surgical Instruments—Metallic Materials—Part 1: Stainless steelTransferred from orthopaedics.67
Ortho 84ISO 13782: 1996, Implants for Surgery—Metallic Materials—Unalloyed tantalum for surgical implant applicationsTransferred from orthopaedics.68
Dental 37ISO 5832-10:1996, Implants for Surgery—Metallic Materials—Part 10: Wrought titanium 5-aluminium 2,5-ironTransferred from dental/ENT.69

F. Ophthalmic

Start Printed Page 10718
Old Item No.StandardChangeReplacement Item No.
30ANSI Z80.7-2002: Ophthalmics—Intraocular LensesCorrection in publication date30

G. Orthopaedics

Old Item No.StandardChangeReplacement Item No.
58ASTM F1781-97, Standard Specification for Elastomeric Flexible Hinge Finger Total Joint ImplantsAdded “Design Controls” to Process(es) Impacted58
62ISO 5832-1:1997, Implants for Surgery—Metallic materials—Part 1: Wrought stainless steelWithdrawn and transferred to Materials62
64ISO 5832-3:1996, Implants for Surgery—Metallic materials—Part 3: Wrought titanium 6-aluminum 4-vanadium alloyWithdrawn and transferred to Materials64
65ISO 5832-4:1996, Implants for Surgery—Metallic materials—Part 4: Cobalt-chromium-molybdenum casting alloyWithdrawn and transferred to Materials65
66ISO 5832-5:1993, Implants for Surgery—Metallic materials—Part 5: Wrought cobalt-chromium-tungsten-nickel alloyWithdrawn and transferred to Materials66
67ISO 5832-6:1997, Implants for Surgery—Metallic materials—Part 6: Wrought cobalt-nickel-chromium-molybdenum alloyWithdrawn and transferred to Materials67
70ISO 5832-11:1994, Implants for Surgery—Metallic materials—Part 11: Wrought titanium 6-aluminum 7-niobium alloyWithdrawn and transferred to Materials70
71ISO 5832-12:1996, Implants for Surgery—Metallic materials—Part 12: Wrought cobalt-chromium-molybdenum alloyWithdrawn and transferred to Materials71
73ISO 5838-1:1995, Implants for Surgery—Skeletal Pins and Wires—Part 1: Material and Mechanical RequirementsAdded “Design Controls” to Process(es) Impacted73
74ISO 5838-2:1991, Implants for Surgery—Skeletal Pins and Wires—Part 2: Steinmann Skeletal Pins—DimensionsAdded “Design Controls” to Process(es) Impacted74
75ISO 5838-3:1993, Implants for Surgery—Skeletal Pins and Wires—Part 3: Kirschner Skeletal WiresAdded “Design Controls” to Process(es) Impacted75
76ISO 6474-94, Implants for surgery—Ceramic materials based on high purity aluminaWithdrawn and transferred to Materials
78ISO 7206-4:2002, Implants for Surgery—Partial and Total Hip Joint Prostheses—Part 4: Determination of Endurance Properties of Stemmed Femoral ComponentsWithdrawn and replaced with newer version; Title change; Added “Design Controls” to Process(es) Impacted165
79ISO 7206-8:1995, Implants for Surgery—Partial and Total Hip Joint Prostheses—Part 8: Endurance Performance of Stemmed Femoral Components with Application of TorsionAdded “Design Controls” to Process(es) Impacted79
83ISO 13402-95, Surgical and Dental Hand Instruments—Determination of Resistance Against Autoclaving, Corrosion and Thermal ExposureAdded “Design Controls” to Process(es) Impacted83
84ISO 13782:1996, Implants for Surgery—Metallic materials—Unalloyed tantalum for surgical implant applicationsWithdrawn and transferred to Materials
85ISO 14630:1997, Non-Active Surgical Implants—General RequirementsAdded “Design Controls” to Process(es) Impacted85
Start Printed Page 10719
101ASTM F897-02, Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and ScrewsWithdrawn and replaced with newer version; Added “Design Controls” to Process(es) Impacted166
104ASTM F1089-02, Standard Test Method for Corrosion of Surgical InstrumentsWithdrawn and replaced with newer version; Added “Design Controls” to Process(es) Impacted167
107ASTM F1147-99, Standard Test Method for Tension Testing of Calcium Phosphate and Metallic CoatingsAdded “Design Controls” to Process(es) Impacted107
111ASTM F1814-97a, Standard Guide for Evaluating Modular Hip and Knee Joint ComponentsAdded “Design Controls” to Process(es) Impacted111
113ASTM F1377-98a, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)Added “Design Controls” to Process(es) Impacted113
114ASTM F1798-97, Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis ImplantsAdded “Design Controls” to Process(es) Impacted114
115ASTM F1800-97, Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint ReplacementsAdded “Design Controls” to Process(es) Impacted115
117ISO 5832-2:1999, Implants for Surgery—Metallic Materials—Part 2: Unalloyed TitaniumWithdrawn and transferred to Materials
118ISO 5832-9:1992, Implants for Surgery—Metallic Materials—Part 9: Wrought High Nitrogen Stainless SteelWithdrawn and transferred to Materials
119ISO 5834-2:1998, Implants for Surgery—Ultra-High-Molecular Weight Polyethylene—Part 2: Moulded FormsWithdrawn and transferred to Materials
120ASTM F382-99, Standard Specification and Test Method for Metallic Bone PlatesAdded “Design Controls” to Process(es) Impacted120
121ISO 7207-1:1994, Implants for Surgery—Components for partial and total knee joint prostheses—Part 1: Classification, definitions and designation of dimensionsAdded “Design Controls” to Process(es) Impacted121
126ASTM F366-82(2000), Standard Specification for Fixation Pins and WiresAdded “Design Controls” to Process(es) Impacted126
131ASTM F1044-99, Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic CoatingsAdded “Design Controls” to Process(es) Impacted131
140ASTM F1582-98, Standard Terminology Relating to Spinal ImplantsAdded “Design Controls” to Process(es) Impacted140
141ASTM F1612-95(2000), Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components With TorsionAdded “Design Controls” to Process(es) Impacted141
142ASTM F1672-95(2000), Standard Specification for Resurfacing Patellar ProsthesisAdded “Design Controls” to Process(es) Impacted142
143ISO 7153-1:1991/Amd. 1:1999, Surgical Instruments—Metallic Materials—Part 1: Stainless steelWithdrawn and transferred to Materials143
152ASTM F1160-00e1, Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic CoatingsAdded “Design Controls” to Process(es) Impacted152
155ISO 7207-2:1998, Implants for Surgery—Components for partial and total knee joint prostheses—Part 2: Articulating surfaces made of metal, ceramic and plastics materialsAdded “Design Controls” to Process(es) Impacted155
Start Printed Page 10720
159ASTM F1717-01, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy ModelAdded “Design Controls” to Process(es) Impacted159
161ASTM F1264-01, Standard Specification and Test Methods for Intramedullary Fixation DevicesAdded “Design Controls” to Process(es) Impacted161
162ASTM F564-02, Standard Specification and Test Methods for Metallic Bone StaplesAdded “Design Controls” to Process(es) Impacted162
163ASTM F543-02 Standard Specification and Test Methods for Metallic Medical Bone ScrewsAdded “Design Controls” to Process(es) Impacted163
164ASTM F1541-02, Standard Specification and Test Methods for External Skeletal Fixation DevicesAdded “Design Controls” to Process(es) Impacted164

H. Radiology

Old Item No.StandardChangeReplacement Item No.
38IEC 60601-2-15, Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Capacitor Discharge X-ray Generators (1988)Withdrawn
43IEC 60601-2-33: Medical Electrical Equipment—Part 2, Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis (2002-2005)Withdrawn and replaced with newer version86
60IEC 61217 (2002-03), Radiotherapy Equipment—Coordinates, movements, and scalesWithdrawn and replaced with newer version87
64IEC 60601-2-45, Ed. 2.0, (2001-05): Medical Electrical Equipment—Part 2-45: Particular Requirements for the Safety of Mammographic X-ray Equipment and Mammographic Stereotactic DevicesCorrection date inserted64
78NEMA PS 3.1 through PS 3.16 2000, Digital Imaging and Communications in Medicine (DICOM)Correction Parts inserted in title78

I. Sterility

Old Item No.StandardChangeReplacement Item No.
1AOAC 6.2.01:2000, Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution MethodWithdrawn and replaced with newer version94
2AOAC 6.2.02:2000, Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test MethodWithdrawn and replaced with newer version95
3AOAC 6.2.03:2000, Official Method 99l.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test MethodWithdrawn and replaced with newer version.96
4AOAC 6.2.04:2000, Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus, Use-Dilution MethodWithdrawn and replaced with newer version97
5AOAC 6.2.05:2000, Official Method 99l.49, Testing Disinfectants Against Pseudomonas aeruginosa, Hard Surface Carrier Test MethodWithdrawn and replaced with newer version98
6AOAC 6.2.06:2000, Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution MethodWithdrawn and replaced with newer version99
Start Printed Page 10721
7AOAC 6.3.02, Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytesWithdrawn and replaced with newer version100
8AOAC 6.3.05:2000, Official Method 966.04, Sporicidal Activity of DisinfectantsWithdrawn and replaced with newer version101
9AOAC 6.3.06:2000, Official Method 965.12, Tuberculocidal Activity of DisinfectantsWithdrawn and replaced with newer version102
24ANSI/AAMI/ISO 11134:1993, Sterilization of Health Care Products—Requirements for Validation and Routine Control-Industrial Moist Heat SterilizationContact person24
25ANSI/AAMI/ISO 11135-1994, Medical Devices—Validation and Routine Control of Ethylene Oxide SterilizationContact person25
27AAMI/ANSI/ISO 11607:2000, Packaging for Terminally Sterilized Medical DevicesWithdrawn and replaced with newer version; Add to Extent of Recognition103
51ANSI/AAMI ST58:1996, Safe Use and Handling of Glutaraldehyde-Based Products in Health Care Facilities and ANSI/AAMI ST58:1996/Amendment 1 2002Withdrawn and replaced with newer version104
52ANSI/AAMI ST59:1999, Sterilization of Health Care Products—Biological Indicators Part 1: General RequirementsUpdated Relevant Guidance52
73ANSI/AAMI ST46:2002, Steam Sterilization and Sterility Assurance in Health Care FacilitiesWithdrawn and replaced with newer version105
75ANSI/AAMI/ISO 11137:1994, Sterilization of Health Care Products-Requirements for Validation and Routine Control-Radiation Sterilization and ISO11137:1995 (Amendment 1:2002)Title Correction; Additional Relevant Guidance; Contact person75
76AAMI/ANSI/ISO 10993-7:1995 (R) 2001, Biological Evaluation of Medical Devices—Part 7: Ethylene Oxide Sterilization ResidualsDelete (e.g. hemodialyzers) from the Extent of Recognition76
78USP 26:2003, Biological Indicator for Dry Heat Sterilization, Paper CarrierWithdrawn and replaced with newer version106
79USP 26:2003, Biological Indicator for Ethylene Oxide Sterilization, Paper CarrierWithdrawn and replaced with newer version107
80USP 26:2003, Biological Indicator for Steam Sterilization, Paper CarrierWithdrawn and replaced with newer version108
81USP 26:2003, <61> Microbial Limits TestWithdrawn and replaced with newer version109
82USP 26:2003, <71>, Microbiological Tests, Sterility TestsWithdrawn and replaced with newer version110
83USP 26:2003, <85> Biological Tests and Assays, Bacterial Endotoxin Test (LA)Withdrawn and replaced with newer version111
84USP 26:2003, <151> Pyrogen Test (USP Rabbit Test)Withdrawn and replaced with newer version112
85USP 26:2003 <1211> Sterilization and Sterility Assurance of Compendial ArticlesWithdrawn and replaced with newer version113
87USP 26:2003, Transfusion and Infusion Assemblies and Similar Medical Devices <161>Withdrawn and replaced with newer version114
93USP 26:2003, Biological Indicator for Steam SterilizationWithdrawn and replaced with newer version115

III. Listing of New Entries

Start Printed Page 10722

The listing of new entries and consensus standards added as “Modifications to the List of Recognized Standards”, under Recognition List Number: 009,” is as follows:

A. Anesthesia

Item No.Title of StandardReference No. and Date
45Standard Specification for Ventilators Intended for use During AnesthesiaF1101-90 (1996)
46Breathing Tubes Intended for use with Anesthetic Apparatus and VentilatorsISO 5367:2000

B. Biocompatibility

Item No.Title of StandardReference No. and Date
79Standard Practice for Extraction of Medical PlasticsASTM F619-02
80Standard Practice for Characterization of ParticlesASTM F1877-98
81Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause ImmunotoxicityASTM F1905-98
82Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell MigrationASTM F2147-01

C. Cardiovascular/Neurology

Item No.Title of StandardReference No. and Date
50Cardiac Defibrillator DevicesANSI/AAMI DF2-1996 (Revision of ANSI/AAMI DF2-1989)
51Automatic External Defibrillators and Remote-Control DefibrillatorsANSI/AAMI DF39-1993

D. Dental/ENT

Item No.Title of StandardReference No. and Date
103Denture Base PolymersANSI/ADA Specification No. 12:1999
104Pit and Fissure SealantsANSI/ADA Specification No. 39: 1999
105Resilient Lining Materials for Removable Dentures, Part 2: Short-Term MaterialsANSI/ADA Specification No. 75: 1997
106Dental Reversible/Irreversible Hydrocolloid Impression Material SystemANSI/ADA Specification No. 82: 1998
107Dental, Water-Based CementsISO 9917-2:1998
108Dentistry, Resilient Lining Materials for Removable Dentures—Part 1: Short-Term MaterialsISO 10139-1:1991
109Dentistry, Reversible-Irreversible Hydrocolloid Impression Material SystemsISO 13716: 1999

E. In Vitro Diagnostic

Start Printed Page 10723
Item No.Title of StandardReference No. and Date
88Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures: Approved GuidelineNCCLS C37-A:1999
89A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved StandardNCCLS C39-A:2000
90Clinical Application of Flow Cytometry: Immunophenotyping of Leukemic Cells; Approved GuidelineNCCLS H43-A:1998
91Interference Testing in Clinical Chemistry; Approved GuidelineNCCLS EP7-A:2002
94User Protocol for Evaluation of Qualitative Test Performance; Approved GuidelineNCCLS EP12-A:2002
95User Demonstration of Performance for Precision and Accuracy; Approved GuidelineNCCLS EP15-A:2001
96Quality Management for Unit-Use Testing; Approved GuidelineNCCLS EP18-A:2002
97Urinalysis and Collection, Transportation, and Preservation of Urine Specimens—Second Edition; Approved GuidelineNCCLS GP16-A2:2001

F. OB-GYN/Gastroenterology

Item No.Title of StandardReference No. and Date
28HemodialyzersANSI/AAMI RD 16:1996/A1:2002 Amendment 1 to ANSI/AAMI RD 16:1996
29Hemodialyzer Blood TubingANSI/AAMI RD 17:1994/A1:2002 Amendment 1 to ANSI/AAMI RD 17:1994

G. Ophthalmic

Item No.Title of StandardReference No. and Date
31Optics and Optical Instruments—Lasers and Laser-related Equipment—Test Method for the Laser-resistance of Surgical Drapes and/or Patient-protective CoversISO 11810:2002
32Optics and Optical Instruments—Lasers and Laser-related Equipment—Determination of Laser Resistance of Tracheal Tube ShaftsISO 11990:2003

H. Radiology

Item No.Title of StandardReference No. and Date
88Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Remote-Controlled Automatically-Driven Gamma-Ray Afterloading Equipment (1989)IEC 60601-2-17 (1989)
89Optics and optical instruments—Lasers and Laser-Related Equipment—Test Method for the Laser-Resistance of Surgical Drapes and/or Patient-Protective CoversISO 11810:2002
90Medical Electrical Equipment—Part 2: Particular Requirements for Medical Electron AcceleratorsIEC 60601-2-1 Amendment 1—Ed. 2.0 (2002-05)
Start Printed Page 10724
91Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Therapeutic X-ray Equipment Operating in the Range 10 kV to 1 MVIEC 60601-2-8 Amendment 1 (1997-98)
92Medical Electrical Equipment—Dosimeters with Ionization Chambers and/or Semi-Conductor Detectors as used in X-ray Diagnostic ImagingIEC 61674 (1997-10)
93Medical Electrical Equipment—Dosimeters with Ionization Chambers and/or Semi-Conductor Detectors as used in X-ray Diagnostic ImagingIEC 61674 Amendment 1 (2002-06)
94Medical Electrical Equipment—Dosimeters with Ionization Chambers as used in RadiotherapyIEC 60731 Amendment 1 (2002-06)

I. Sterility

Item No.Title of StandardReference No. and Date
116Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch TestingANSI/AAMI ST72:2002

J. Tissue Engineering

Item No.Title of StandardReference No. and Date
3Standard Guide for Characterization of Type 1 Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical ProductsASTM F2212-2002

IV. List of Recognized Standards

FDA maintains the agency's current list of “FDA Recognized Consensus Standards” in a searchable database that may be accessed directly at FDA's Internet site at http://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfStandards/​search.cfm. FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (See FOR FURTHER INFORMATION CONTACT). To be properly considered such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity.

VI. Electronic Access

In order to receive “Guidance on the Recognition and Use of Consensus Standards” via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt press 1 to order a document. Enter the document number 321 followed by the pound sign (#). Follow the remaining voice prompts to complete your request.

You may obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the Federal Register, this notice announcing “Modification to the List of Recognized Standards, Recognition List Number: 009” will be available on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/​cdrh. You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for “FDA Recognized Consensus Standards,” through hyperlink at http://www.fda.gov/​cdrh/​stdsprog.html. This Federal Register notice of modifications in FDA's recognition of consensus standards will be available, upon publication, at http://www.fda.gov/​cdrh/​fedregin.html.

VII. Submission of Comments and Effective Date

Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) written or electronic comments regarding this document. Two copies of any mailed comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of “Modifications to the List of Recognized Standards, Recognition List Number: Start Printed Page 10725009.” These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register.

Start Signature

Dated: February 13, 2004.

Beverly Chernaik Rothstein,

Acting Deputy Director for Policy and Regulations, Center for Devices and Radiological Health.

End Signature End Preamble

[FR Doc. E4-479 Filed 3-5-04; 8:45 am]

BILLING CODE 4160-01-S