A. Anesthesia |
1-58 | 1-99 | ASTM G175-13 Standard test method for evaluating the ignition sensitivity and fault tolerance of oxygen pressure regulators used for medical and emergency applications | Withdrawn and replaced with newer version. |
1-77 | 1-100 | CGA V1:2013 Standard for compressed gas cylinder valve outlet and inlet connections | Withdrawn and replaced with newer version. |
1-80 | 1-101 | CGA C-9:2013 Standard color marking of compressed gas containers for medical use | Withdrawn and replaced with newer version. |
B. Biocompatibility |
2-117 | | ANSI/AAMI/ISO 10993-3:2003/(R) 2013 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity | Reaffirmation. |
2-133 | | ASTM F1408-97 (Reapproved 2013) Standard practice for subcutaneous screening test for implant materials | Reaffirmation. |
2-136 | | ASTM E1262-88 (Reapproved 2013) Standard guide for performance of the Chinese hamster ovary cell/hypoxanthine guanine phosphoribosyl transferase gene mutation assay | Reaffirmation. |
2-141 | | ASTM F1984-99 (Reapproved 2013) Standard practice for testing for whole complement activation in serum by solid materials | Reaffirmation. |
2-145 | | ASTM F1439-03 (Reapproved 2013) Standard guide for performance of lifetime bioassay for the tumorigenic potential of implant materials | Reaffirmation. |
2-146 | 2-206 | ASTM F2148-13 Standard practice for evaluation of delayed contact hypersensitivity using the murine local lymph node assay (LLNA) | Withdrawn and replaced with newer version. |
2-153 | | ANSI/AAMI/ISO 10993-5:2009/(R) 2014 Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity | Reaffirmation. |
Start Printed Page 38912 |
2-154 | 2-207 | ASTM F756-13 Standard practice for assessment of hemolytic properties of materials | Withdrawn and replaced with newer version. |
2-156 | | ANSI/AAMI/ISO 10993-1:2009/(R) 2013 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process | Reaffirmation. |
2-175 | | ISO 10993-3 Second edition 2003-10-15, Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity | Extent of recognition. |
2-199 | 2-208 | USP 37-NF32:2014 <87> Biological reactivity test, in vitro—direct contact test | Withdrawn and replaced with newer version. |
2-200 | 2-209 | USP 37-NF32:2014 <87> Biological reactivity test, in vitro—elution test | Withdrawn and replaced with newer version. |
2-201 | 2-210 | USP 37-NF32:2014 <88> Biological reactivity test, in vivo, procedure preparation of sample | Withdrawn and replaced with newer version. |
2-202 | 2-211 | USP 37-NF32:2014 <88> Biological reactivity test, in vitro, classification of plastics—intracutaneous test | Withdrawn and replaced with newer version. |
2-203 | 2-212 | USP 37-NF32:2014 <88> Biological reactivity test, in vivo, classification of plastics—systemic injection test | Withdrawn and replaced with newer version. |
C. Cardiovascular |
3-42 | | ANSI/AAMI EC13:2002/(R)2007 Cardiac monitors, heart rate meters, and alarm | Withdrawn. See 3-101. |
3-65 | | ANSI/AAMI EC38:2007 Medical electrical equipment—Part 2-47: Particular requirements for the safety including essential performance of ambulatory electrocardiographic systems | Withdrawn. See 3-127. |
3-72 | 3-129 | ANSI/AAMI EC53:2013 ECG trunk cables and patient lead wires | Withdrawn and replaced with newer version. |
3-77 | | ANSI/AAMI PC69:2007 Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators | Withdrawn. See 3-128. |
3-78 | 3-130 | ANSI/AAMI/ISO 80601-2-30:2009 and A1:2013 Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers [Amendment 1:2013] | Withdrawn and replaced with newer version. |
3-79 | | F2070-09 (Reapproved 2013) Standard test method for measuring intrinsic elastic recoil of balloon-expandable stents | Reaffirmation. |
3-82 | 3-125 | ISO 5841 Third edition 2013-04-15 Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors [IS-1] for implantable pacemakers | Withdrawn and replaced with newer version. |
3-95 | 3-126 | IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)] | Withdrawn and replaced with newer version including technical corrigendum. |
D. Dental/ENT |
4-92 | | ANSI/ADA Standard No. 88 (Reaffirmed 2012) Dental brazing alloys | Reaffirmation. |
4-96 | | ANSI/ADA Specification No. 30 (Reaffirmed 2010) Dental zinc oxide—eugenol and zinc oxide—non-eugenol cements | Reaffirmation. |
4-97 | | ANSI/ADA Standard No. 57 (Reaffirmed 2012) Endodontic sealing materials | Reaffirmation. |
4-149 | | ANSI/ADA Specification No. 39 (Reaffirmed 2011) Pit and fissure sealants | Reaffirmation. |
4-160 | | ANSI S3.1 (Reaffirmed 2013) Maximum permissible ambient noise levels for audiometric test rooms | Reaffirmation. |
4-162 | | ANSI S3.4-2007 (Reaffirmed 2012) Procedure for the computation of loudness of steady sounds | Reaffirmation. |
4-163 | | ANSI S3.5-1987 (Reaffirmed 2012) American national standard methods for calculation of the speech intelligibility index | Reaffirmation. |
4-165 | | ANSI S3.13-1987 (Reaffirmed 2012) American national standard mechanical coupler for measurement of bone vibrators | Reaffirmation. |
4-171 | | ANSI S3.37-1987 (Reaffirmed 2012) American national standard preferred earhook nozzle thread for postauricular hearing aids | Reaffirmation. |
4-175 | 4-211 | ANSI S3.46-2013 American national standard method of measurement of real-ear performance characteristics of hearing aids | Withdrawn and replaced with newer version. |
4-177 | | ANSI S12.65-2006 (Reaffirmed 2011) American national standard for rating noise with respect to speech interference | Reaffirmation. |
Start Printed Page 38913 |
4-179 | 4-212 | ISO 7405 Second edition 2008-12-15 Dentistry—Evaluation of biocompatibility of medical devices used in dentistry [Including: Amendment 1 (2013)] | Withdrawn and replaced with newer version including amendment. |
4-193 | | ANSI/ADA Standard No. 15 (Reaffirmed 2013) Artificial teeth for dental prostheses | Reaffirmation. |
E. General I (Quality Systems/Risk Management (QS/RM)) |
5-22 | | ISO 2768-l First edition 1999-11-15 General tolerances—Part 1: Tolerances for linear and angular dimensions without individual tolerance indications | Withdrawn. |
5-23 | | ISO 2768-2 First edition 1989-11-15 General tolerances—Part 2: Geometrical tolerances for features without individual tolerance indications | Withdrawn. |
5-50 | 5-87 | IEC 62366 Edition 1.1 2014-01 Medical devices—Application of usability engineering to medical devices | Withdrawn and replaced with newer version. |
5-53 | 19-1 | IEC 60601-1-2 Edition 3:2007-03 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and tests | Transferred to General II (ES/EMC). |
5-54 | 19-2 | ANSI/AAMI/IEC 60601-1-2:2007/(R)2012 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and tests | Transferred to General II (ES/EMC). |
5-66 | 19-3 | IEC 60601-1-10 Edition 1.0 2007-11 Medical electrical equipment—Part 1-10: General requirements for basic safety and essential performance—Collateral standard: Requirements for the development of physiologic closed-loop controllers | Transferred to General II (ES/EMC). |
5-77 | 19-4 | ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012 (consolidated text) Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, mod) | Transferred to General II (ES/EMC). |
5-78 | 19-5 | ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 (consolidated text) Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, mod) | Transferred to General II (ES/EMC). |
5-81 | 5-88 | ISO 2859-1 First edition 1999-11-15 Sampling procedures for inspection by attributes—Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Corrigendum 1 (2001), Amendment 1 (2011)] | Withdrawn and replaced with newer version including amendment. |
5-82 | 19-6 | IEC 60601-1-11 Edition 1.0 2010-04 Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment [including: Technical corrigendum 1 (2011)] | Transferred to General II (ES/EMC). |
5-83 | 19-7 | ANSI/AAMI HA60601-1-11:2011 Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2010 mod) | Transferred to General II (ES/EMC). |
5-85 | | IEC 60601-1-6 Edition 3.0 2010-01 Medical electrical equipment—Part 1-6: General requirements for basic safety and essential performance—Collateral standard: Usability | Transition period added. |
5-73 | 5-90 | ISO 15223-1 Second edition 2012-07-01 Medical devices—Symbols to be used with medical device labels, labeling, and information to be supplied—Part 1: General requirements | Extent of recognition. |
5-75 | 5-91 | AAMI/ANSI/ISO 15223-1:2012 Medical devices—Symbols to be used with medical devices labels, labeling, and information to be supplied—Part 1: General requirements | Extent of recognition. |
5-57 | | AAMI/ANSI HE75:2009 Human factors engineering—Design of medical devices | Relevant guidance. |
5-67 | | ANSI/AAMI/IEC 62366:2007/(R)2013 Medical devices—Application of usability engineering to medical devices | Relevant guidance. |
F. General Hospital/General Plastic Surgery |
6-180 | | ASTM F2407-06 (Reapproved 2013) Standard specification for surgical gowns intended for use in healthcare facilities | Reaffirmation. |
Start Printed Page 38914 |
6-184 | 6-323 | ASTM F1862/F1862M-13 Standard test method for resistance of medical face masks to penetration by synthetic blood (horizontal projection of fixed volume at a known velocity) | Withdrawn and replaced with newer version. |
6-234 | 6-324 | IEC 60601-2-50 Edition 2.0 2009-03 Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Technical corrigendum 1 (2010)] | Withdrawn and replaced with newer version including technical corrigendum. |
6-300 | 6-325 | IEC 60601-2-21 Edition 2.0 2009-02 Medical electrical equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Technical corrigendum 1 (2013)] | Withdrawn and replaced with newer version including technical corrigendum. |
6-309 | 6-326 | USP 37-NF 33:2014 Sodium chloride irrigation | Withdrawn and replaced with newer version. |
6-310 | 6-327 | USP 37-NF 33:2014 Sodium chloride injection | Withdrawn and replaced with newer version. |
6-311 | 6-328 | USP 37-NF 33:2014 Nonabsorbable surgical suture | Withdrawn and replaced with newer version. |
6-312 | 6-329 | USP 37-NF 33:2014 <881> Tensile strength | Withdrawn and replaced with newer version. |
6-313 | 6-330 | USP 37-NF 33:2014 <861> Sutures—Diameter | Withdrawn and replaced with newer version. |
6-314 | 6-331 | USP 37-NF 33:2014 <871> Sutures—Needle attachment | Withdrawn and replaced with newer version. |
6-315 | 6-332 | USP 37-NF 33:2014 Sterile water for irrigation | Withdrawn and replaced with newer version. |
6-316 | 6-333 | USP 37-NF 33:2014 Heparin lock flush solution | Withdrawn and replaced with newer version. |
6-317 | 6-334 | USP 37-NF 33:2014 Absorbable surgical suture | Withdrawn and replaced with newer version. |
G. In Vitro Diagnostics |
7-48 | | CLSI C60-A (Formerly T/DM06-A) Blood alcohol testing in the clinical laboratory; Approved guideline | Designation number. |
7-112 | | CLSI POCT14-A (Formerly H49-A) Point-of-care monitoring of anticoagulation therapy; Approved guideline | Designation number. |
7-133 | 7-246 | CLSI POCT12-A3 Point-of-care blood glucose testing in acute and chronic care facilities; Approved guideline—Third edition | Withdrawn and replaced with newer version. |
7-142 | | CLSI GP43-A4 (Replaces H11-A4) Procedures for the collection of arterial blood specimens; Approved standard—Fourth edition | Designation number. |
7-162 | | CLSI POCT14-A (Formerly H49-A) Point-of-care monitoring of anticoagulation therapy; Approved guideline | Designation number. |
7-175 | | CLSI C59-A (Formerly I/LA15-A) Apolipoprotein immunoassays: Development and recommended performance characteristics; Approved guideline | Designation number. |
7-201 | | CLSI GP41-A6 (Replaces H03-A6) Procedures for the collection of diagnostic blood specimens by venipuncture; Approved standard—Sixth edition | Designation number. |
7-203 | | CLSI GP42-A6 (Replaces H04-A6) Procedures and devices for the collection of diagnostic capillary blood specimens; Approved standard—Sixth edition | Designation number. |
7-213 | | CLSI GP44-A4 (Replaces H18-A4) Procedures for the handling and processing of blood specimens for common laboratory tests; Approved guideline—Fourth edition | Designation number. |
7-221 | | CLSI GP39-A6 (Replaces H01-A6) Tubes and additives for venous and capillary blood specimen collection; Approved standard—Sixth edition | Designation number. |
7-241 | 7-247 | CLSI M100-S24 Performance standards for antimicrobial susceptibility testing; Twenty-fourth informational supplement | Withdrawn and replaced with newer version. |
H. Materials |
8-173 | 8-371 | ASTM F601-13 Standard practice for fluorescent penetrant inspection of metallic surgical implants | Withdrawn and replaced with newer version. |
8-183 | 8-372 | ASTM F560-13 Standard specification for unalloyed tantalum for surgical implant applications (UNS R05200, UNS R05400) | Withdrawn and replaced with newer version. |
8-193 | | ASTM F2754/F2754M-09 (Reapproved 2013) Standard test method for measurement of camber, cast, helix, and direction of helix of coiled wire | Reaffirmation. |
Start Printed Page 38915 |
8-198 | 8-373 | ASTM F2102-13 Standard guide for evaluating the extent of oxidation in polyethylene fabricated forms intended for surgical implants | Withdrawn and replaced with newer version. |
8-199 | 8-374 | ASTM F2633-13 Standard specification for wrought seamless nickel-titanium shape memory alloy tube for medical devices and surgical implants | Withdrawn and replaced with newer version. |
8-221 | 8-375 | ASTM F2066-13 Standard specification for wrought titanium-15 molybdenum alloy for surgical implant applications (UNS R58150) | Withdrawn and replaced with newer version. |
8-224 | 8-376 | ASTM F2102-13 Standard guide for evaluating the extent of oxidation in polyethylene fabricated forms intended for surgical implants | Withdrawn and replaced with newer version. |
8-341 | 8-377 | ASTM F136-13 Standard specification for wrought titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy for surgical implant applications (UNS R56401) | Withdrawn and replaced with newer version. |
8-364 | 8-378 | ASTM D792-13 Standard test methods for density and specific gravity (relative density) of plastics by displacement | Withdrawn and replaced with newer version. |
8-366 | 8-379 | ISO 11542-2 First edition 1998-11-15 Plastics—Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials—Part 2: Preparation of test specimens and determination of properties [Including: Technical corrigendum 1 (2007)] | Withdrawn and replaced with newer version including technical corrigendum. |
I. Nanotechnology |
18-2 | | ASTM E2535-07 (Reapproved 2013) Standard guide for handling unbound engineered nanoscale particles in occupational settings | Reaffirmation. |
J. Neurology |
17-10 | | ANSI/AAMI/ISO 14708-3:2008/(R)2011 Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators | Reaffirmation. |
K. OB-GYN/Gastroenterology/Urology |
9-44 | | ASTM F623-99 (Reapproved 2013) Standard performance specification for Foley catheter | Reaffirmation. |
9-87 | 9-93 | ISO 25841 Second edition 2014-01-15 Female condoms—Requirements and test methods | Withdrawn and replaced with newer version. |
9-21 | 9-94 | ISO 8600-4 Second edition 2014-03-15 Optics and optical instruments—Medical endoscopes and certain accessories—Part 4: Determination of maximum width of insertion portion | Withdrawn and replaced with newer version. |
L. Orthopedic |
11-211 | 11-276 | ASTM F1798-13 Standard test method for evaluating the static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants | Withdrawn and replaced with newer version. |
11-237 | 11-277 | ISO 7206-6 Second edition 2013-11-15 Implants for surgery—Partial and total hip joint prostheses—Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components | Withdrawn and replaced with newer version. |
11-255 | 11-278 | ASTM F1717-14 Standard test methods for spinal implant constructs in a vertebrectomy model | Withdrawn and replaced with newer version. |
M. Radiology |
12-23 | | NEMA XR 10-1986 (R1992, R1998, R2003) Measurement of the maximum symmetrical radiation field from a rotating anode x-ray tube used for medical diagnosis | Withdrawn. |
12-24 | | NEMA XR 11-1993 (R1999) Test standard for determination of the limiting spatial resolution of x-ray image intensifier systems | Withdrawn. |
12-25 | | NEMA XR 15-1991 (R1996, R2001) Test standard for the determination of the visible entrance field size of an x-ray image intensifier system | Withdrawn. |
12-26 | | NEMA XR 16-1991 (R1996, R2001) Test standard for the determination of the system contrast ratio and the system veiling glare index of an x-ray image intensifier system | Withdrawn. |
12-27 | | NEMA XR 17-1993 (R1999) Test standard for the measurement of the image signal uniformity of an x-ray image intensifier system | Withdrawn. |
Start Printed Page 38916 |
12-28 | | NEMA XR 18-1993 (R1999) Test standard for the determination of the radial image distortion of an x-ray image intensifier system | Withdrawn. |
12-29 | | NEMA XR 19-1993 (R1999) Electrical, thermal, and loading characteristics of x-ray tubes used for medical diagnosis | Withdrawn. |
12-66 | 12-271 | AIUM MUS Medical ultrasound safety, third edition | Withdrawn and replaced with newer version. |
12-79 | | NEMA XR7-1995 (R2000) High-voltage x-ray cable assemblies and receptacles | Withdrawn. |
12-80 | | NEMA XR 9-1984 (R1994, R2000) Power supply guidelines for x-ray machines | Withdrawn. |
12-81 | | NEMA XR 13-1990 (R1995, R2000) Mechanical safety standard for power driven motions of electromedical equipment | Withdrawn. |
12-82 | | NEMA XR 14-1990 (R1995, R2000) Recommended practices for load bearing mechanical assemblies used in diagnostic imaging | Withdrawn. |
12-100 | | NEMA UD 3-2004 (R2009) Standard for real time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment | Withdrawn |
12-146 | 12-272 | IEC 60601-2-17 Edition 3.0 2013-11 Medical electrical equipment—Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment | Withdrawn and replaced with newer version. |
12-168 | 12-273 | IEC 60825-1 Edition 2.0 2007-03 Safety of laser products—Part 1: Equipment classification and requirements [Including: Technical corrigendum 1 (2008), interpretation sheet 1 (2007), interpretation sheet 2 (2007)] | Withdrawn and replaced with newer version including technical corrigendum and interpretation sheets. |
12-193 | | AIUM AOL 2008 Acoustic output labeling standard for diagnostic ultrasound equipment revision 1—A standard for how manufacturers should specify acoustic output data | Withdrawn. |
12-194 | | ANSI/HPS N43.6-2007 (R2013) Sealed radioactive sources—Classification | Reaffirmation. |
12-201 | 12-274 | IEC 60601-2-54 Edition 1.0 2009-06 Medical electrical equipment—Part 2-54: Particular requirements for the basic safety and essential performance of x-ray equipment for radiography and radioscopy [Including: Technical corrigendum 1 (2010), technical corrigendum 2 (2011)] | Withdrawn and replaced with newer version including technical corrigendum. |
12-220 | | IEC 60825-1 (Second edition-2007) Safety of laser products—Part 1: Equipment classification and requirements corrigendum 1 | Withdrawn. See 12-273. |
12-239 | | IEC 60825-1 (Second edition-2007) I-SH 01 Safety of laser products—Part 1: Equipment classification and requirements, interpretation sheet 1 | Withdrawn. See 12-273. |
12-240 | | IEC 60825-1 (2007) Second edition, I-SH 02 Safety of laser products—Part 1: Equipment classification and requirements, interpretation sheet 2 | Withdrawn. See 12-273. |
N. Software/Informatics |
13-4 | 13-65 | ANSI/UL 1998 Third edition 2013 Standard for software in programmable components | Withdrawn and replaced with newer version. |
13-15 | | CLSI AUTO13-A2 Laboratory instruments and data management systems: Design of software user interfaces and end-user software systems validation, operation, and monitoring; Approved guideline—second edition | New designation number. |
13-46 | | ASTM F2761-09 (2013) Medical devices and medical systems—Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model | Reaffirmation. |
13-58 | 13-66 | ISO/IEEE 11073-10417 First edition 2014-03-01 Health informatics—Personal health device communication—Part 10417: Device specialization: Glucose meter | Withdrawn and replaced with newer version. |
O. Sterility |
14-181 | 14-432 | ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities | Withdrawn and replaced with newer version. |
14-228 | | ANSI/AAMI/ISO 11135-1:2007 Sterilization of healthcare products—Ethylene oxide—Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices | Withdrawn. See 14-452. |
Start Printed Page 38917 |
14-232 | 14-433 | ASTM F2227-13 Standard test method for non-destructive detection of leaks in non-sealed and empty packaging trays by CO2 tracer gas method | Withdrawn and replaced with newer version. |
14-233 | 14-434 | ASTM F2228-13 Standard test method for non-destructive detection of leaks in packaging which incorporates porous barrier material by CO2 tracer gas method | Withdrawn and replaced with newer version. |
14-256 | | ASTM F2095-07 (Reapproved 2013) Standard test methods for pressure decay leak test for flexible packages with and without restraining plates | Reaffirmation. |
14-257 | | ASTM D3078-02 (Reapproved 2013) Standard test method for determination of leaks in flexible packaging by bubble emission | Reaffirmation. |
14-259 | 14-435 | ASTM F2251-13 Standard test method for thickness measurement of flexible packaging material | Withdrawn and replaced with newer version. |
14-261 | | ANSI/AAMI/ISO 17665-1:2006/(R)2013 Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices | Reaffirmation. |
14-282 | | ASTM F2338-09 (Reapproved 2013) Standard test method for nondestructive detection of leaks in packages by vacuum decay method | Reaffirmation. |
14-286 | | ANSI/AAMI ST65:2008/(R)2013 Processing of reusable surgical textiles for use in health care facilities | Reaffirmation. |
14-288 | | ASTM F1886/F1886M-09 (Reapproved 2013) Standard test method for determining integrity of seals for flexible packaging by visual inspection | Reaffirmation. |
14-290 | | ANSI/AAMI ST24:1999/(R)2013 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities | Reaffirmation. |
14-291 | | ANSI/AAMI/ISO 14937:2009/(R)2013 Sterilization of healthcare products—General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices | Reaffirmation. |
14-331 | 14-452 | ISO 11135 Second edition 2014 Sterilization of healthcare products—Ethylene oxide—Requirements for the development, validation, and routine control of a sterilization process for medical devices | Withdrawn and replaced with newer version. |
14-342 | | ASTM E2628-09 (E2009) Standard practice for dosimetry in radiation | Withdrawn. See 14-436. |
13-343 | | ASTM E2701-09 Standard guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing | Withdrawn. See 14-437. |
14-348 | | ANSI/AAMI/ISO 13408-2:2003/(R)2013 Aseptic processing of healthcare products—Part 2: Filtration | Reaffirmation. |
14-364 | 14-438 | ANSI/AAMI/ISO 11137-2:2013 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose | Withdrawn and replaced with newer version. |
14-394 | 14-439 | ANSI/AAMI ST79:2010, A1:2010, A2:2011, A3:2012, and A4:2013 (consolidated text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities | Withdrawn and replaced with newer version. |
14-414 | 14-440 | USP 37NF32:2014 Microbiological examination of nonsterile products: Microbial enumeration tests | Withdrawn and replaced with newer version. |
14-415 | 14-441 | USP 37NF32:2014 Sterility tests | Withdrawn and replaced with newer version. |
14-416 | 14-442 | USP 37NF32:2014 Bacterial endotoxins test | Withdrawn and replaced with newer version. |
14-417 | 14-443 | USP 37NF32:2014 Pyrogen test (USP rabbit test) | Withdrawn and replaced with newer version. |
14-418 | 14-444 | USP 37NF32:2014 Transfusion and infusion assemblies and similar medical devices | Withdrawn and replaced with newer version. |
14-419 | 14-445 | USP 37NF32:2014 Biological indicator for steam sterilization—Self-contained | Withdrawn and replaced with newer version. |
14-420 | 14-446 | USP 37NF32:2014 Biological indicator for dry-heat sterilization, paper carrier | Withdrawn and replaced with newer version. |
14-421 | 14-447 | USP 37NF32:2014 Biological indicator for ethylene oxide sterilization, paper carrier | Withdrawn and replaced with newer version. |
14-422 | 14-448 | USP 37NF32:2014 Biological indicator for steam sterilization, paper carrier | Withdrawn and replaced with newer version. |
14-423 | 14-449 | USP 37NF32:2014 Microbiological examination of nonsterile products: Tests for specified microorganisms | Withdrawn and replaced with newer version. |
Start Printed Page 38918 |
14-425 | | ANSI/AAMI/ISO 13408-6:2005/(R)2013 and A1:2013 Aseptic processing of healthcare products—Part 6: Isolator systems | Reaffirmation. |
P. Tissue Engineering |
15-21 | 15-39 | ASTM F2150-13 Standard guide for characterization and testing of biomaterial scaffolds used in tissue-engineered medical products(TEMPs) | Withdrawn and replaced with newer version. |
15-26 | 15-40 | ASTM F2211-13 Standard classification for tissue-engineered medical products (TEMPs) | Withdrawn and replaced with newer version. |
15-33 | 15-41 | ASTM F2602-13 Standard test method for determining the molar mass of chitosan and chitosan salts by size exclusion chromatography with multi-angle light scattering detection (SEC-MALS) | Withdrawn and replaced with newer version. |