| Anaesthetic and Respiratory |
CAN/CSA-Z168.5.1-97 (R2001)
Anaesthesia Ventilators |
ISO 11196:1995
Anaesthetic gas monitors
ISO 11196:1995/Cor 1:1997 |
CSA 11196-98 (R2003)
Anaesthetic Gas Monitors |
ISO 7199:1996
Cardiovascular implants and artificial organs -- Blood-gas exchangers (oxygenators) |
ISO 9919:2005
Medical electrical equipment -- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
CSA Z9919-94 (R2004)
Pulse Oximeters for Medical Use - Requirements |
| Biocompatibility |
ISO 10993-10:2002
Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity |
CSA 10993-10- 98 (R2003)
Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Sensitization |
ISO 10993-11:1993
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity |
CSA 10993.11- 98 (R2002)
Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity |
ISO 10993-13:1998
Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices |
ISO 10993-14:2001
Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics |
ISO 10993-15:2000
Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys |
ISO 10993-16:1997
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables |
ISO 10993-4:2002
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood |
CSA 10993.4- 97 (R2001)
Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions With Blood |
ISO 10993-5:1999
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity |
CSA 10993-5- 01
Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity |
ISO 10993-6:1994
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation |
CSA 10993.6- 97 (R2001)
Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation |
ISO 10993-7:1995
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals |
CSA 10993.7- 98 (R2002)
Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals |
ISO 10993-9:1999
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products |
ISO 10993-1:2003
Biological evaluation of medical devices -- Part 1: Evaluation and testing |
CSA 10993-1- 01
Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing |
ISO 10993-2:1992
Biological evaluation of medical devices -- Part 2: Animal welfare requirements |
CSA 10993.2- 97 (R2001)
Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements |
ISO 10993-3:2003
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
CSA 10993.3- 97 (R2001)
Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity |
ISO 10993-12:2002
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials |
CSA 10993.12- 98 (R2002)
Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials |
ISO 10993-17:2002
Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances |
| Cardiovascular |
ISO 11318:2002
Cardiac defibrillators -- Connector assembly DF-1 for implantable defibrillators -- Dimensions and test requirements |
ISO 14708-1:2000
Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
ISO 5840:2005
Cardiovascular implants -- Cardiac valve prostheses |
CSA 5840-98 (R2002)
Cardiovascular Implants - Cardiac Valve Prostheses |
ISO 5841-3:2000
Implants for surgery -- Cardiac pacemakers -- Part 3: Low-profile connectors (IS-1) for implantable pacemakers
ISO 5841-3:2000/Cor 1:2003 |
CSA 5841-3-01
Implants for Surgery - Cardiac Pacemakers - Part 3: Low-Profile Connectors (IS-1) for Implantable Pacemakers |
IEC 60601-2-25 - Ed. 1.0 : 1993-03-19
Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographs
IEC 60601-2-25-am1 - Ed. 1.0 : 1999-05-07 |
| Contraceptive Devices |
ISO 4074:2002
Natural latex rubber condoms -- Requirements and test methods |
| Dental |
ISO 10271:2001
Dental metallic materials -- Corrosion test methods
ISO 10271:2001/Cor 1:2005 |
ISO 4049:2000
Dentistry -- Polymer-based filling, restorative and luting materials |
ISO 6871-1:1994
Dental base metal casting alloys -- Part 1: Cobalt-based alloys
ISO 6871-1:1994/Cor 1:1998
ISO 6871-1:1994/Amd 1:2005 |
ISO 6871-2:1994
Dental base metal casting alloys -- Part 2: Nickel-based alloys
ISO 6871-2:1994/Amd 1:2005 |
ISO 6872:1995
Dental ceramic
ISO 6872:1995/Amd 1:1997 |
ISO 6876:2001
Dental root canal sealing materials |
ISO 7405:1997
Dentistry -- Preclinical evaluation of biocompatibility of medical devices used in dentistry -- Test methods for dental materials |
ISO 8891:1998
Dental casting alloys with noble metal content of at least 25 % but less than 75 % |
ISO 9693:1999
Metal-ceramic dental restorative systems
ISO 9693:1999/Amd 1:2005 |
ISO 9917-2:1998
Dental water-based cements -- Part 2: Light-activated cements |
ISO 3107:2004
Dentistry -- Zinc oxide/eugenol and zinc oxide/non-eugenol cements
ISO 3107:2004/Cor 1:2006 |
ISO 6874:2005
Dentistry -- Polymer-based pit and fissure sealants |
ISO 6877:2006
Dentistry -- Root-canal obturating points |
ISO 9917-1:2003
Dentistry -- Water-based cements -- Part 1: Powder/liquid acid-base cements |
ISO 24234:2004
Dentistry -- Mercury and alloys for dental amalgam |
| Electromedical |
IEC 60601-1 - Ed. 3.0 : 2005-12-15
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
IEC 60601-1-4 - Consol. Ed. 1.1 (incl. am1) : 2000-04-07
Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
IEC 60601-2-10 - Ed. 1.0 : 1987-12-30
Medical electrical equipment. Part 2: Particular requirements for the safety of nerve and muscle stimulators
IEC 60601-2-10-am1 - Ed. 1.0 : 2001-09-26 |
IEC 60601-2-2 - Ed. 3.0 : 1998-09-23
Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment |
IEC 60601-2-23 - Ed. 2.0 : 1999-12-10
Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment |
IEC 60601-2-27 - Ed. 2.0 : 2005-08-29
Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment |
IEC 60601-2-30 - Ed. 2.0 : 1999-12-22
Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
IEC 60601-2-31 - Ed. 1.0 : 1994-10-12
Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source
IEC 60601-2-31-am1 - Ed. 1.0 : 1998-01-30 |
IEC 60601-2-4 - Ed. 2.0 : 2002-08
Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators |
IEC 60601-2-5 - Ed. 2.0 : 2000-07-13
Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment |
ANSI/AAMI DF80:2003
Medical electrical equipment, Part 2: Particular requirements for the safety of cardiac defibrillators [including automated external defibrillators] |
ANSI/AAMI PC69:2000
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators |
IEC 60529 - Consol. Ed. 2.1 (incl. am1) : 2001-02-27
Degrees of protection provided by enclosures (IP Code) |
IEC 60601-1-8 Ed. 1.0 : 2003-08
Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-8-Am1 Ed. 1.0 : 2006-03 |
IEC 60601-2-18 - Ed. 2.0 : 1996-08-07
Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
IEC 60601-2-18-am1 - Ed. 2.0 : 2000-07-13 |
IEC 60601-2-24 - Ed. 1.0 : 1998-02-19
Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers |
IEC 60601-2-26 - Ed. 2.0 : 2002-11
Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs |
IEC 60601-2-33 - Ed. 2.0 : 2002-05-22
Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
IEC 60601-2-33-am1 - Ed. 2.0 : 2005-08-30 |
IEC 60601-2-34 - Ed. 2.0 : 2000-10
Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment |
IEC 60601-2-49 - Ed. 1.0 : 2001-07-24
Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment |
IEC 60601-2-51 - Ed. 1.0 : 2003-02-27
Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
IEC 60601-2-47 - Ed. 1.0 : 2001-07-10
Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems |
| General Hospital |
ASTM F1585-00
Standard Guide for Integrity Testing of Porous Barrier Medical Packages |
ASTM F1929-98(2004)
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
IEC 60601-2-38 - Ed. 1.0 : 1996-10-30
Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds
IEC 60601-2-38-am1 - Ed. 1.0 : 1999-12-17 |
ISO 11193-1:2002
Single-use medical examination gloves -- Part 1: Specification for gloves made from rubber latex or rubber solution
ISO 11193-1:2002/Cor 1:2005 |
ISO 14971:2000
Medical devices -- Application of risk management to medical devices
ISO 14971:2000/Amd 1:2003 |
CAN/CSA-ISO 14971-01
Medical Devices - Application of Risk Management to Medical Devices
CAN/CSA-ISO 14971A-01 (2003) |
| In Vitro Devices |
CLSI EP05-A2 : 2004-08-20
Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition |
CLSI H15-A3 : 2000-12-01
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition |
CLSI H20-A : 1992-03-01
Reference Leukocyte Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard |
CLSI EP12-A : 2002-08-20
User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline |
IEC 61010-1: 2001-02-01
Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements-Second Edition;
Corrigendum 1:05/2002; Corrigendum 2:04/2003 |
IEC 61010-2-101: 2002-01-01
Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 2-101: Particular Requirements for in Vitro Diagnostic (IVD) Medical Equipment-First Edition |
IEC 61326-1: 2005-12-01
Electrical equipment for measurement, control and laboratory use EMC requirements Part 1: General requirements-Edition 1.0 |
| Material Standard |
ASTM F1091-02
Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605) |
ASTM F1295-05
Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700) |
ASTM F1314-01
Standard Specification for Wrought Nitrogen Strengthened 22 Chromium - 13 Nickel - 5 Manganese - 2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants
(UNS S20910) |
ASTM F1341-99
Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical Implant Applications |
ASTM F1350-02
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) |
ASTM F1537-00
Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
ASTM F1580-01
Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants |
ASTM F1586-02
Standard Specification for Wrought Nitrogen Strengthened 21 Chromium--10 Nickel--3 Manganese--2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675) |
ASTM F562-02
Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
ASTM F603-00
Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application |
ASTM F620-00
Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants |
ASTM F621-02
Standard Specification for Stainless Steel Forgings for Surgical Implants |
ASTM F67-00
Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) |
ASTM F688-05
Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) |
ASTM F745-00
Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications |
ASTM F75-01
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
ASTM F799-02
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) |
ASTM F899-02
Standard Specification for Stainless Steel for Surgical Instruments |
ASTM F90-01
Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) |
ISO 13402:1995
Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure |
ISO 13782:1996
Implants for surgery -- Metallic materials -- Unalloyed tantalum for surgical implant applications |
ISO 5832-11:1994
Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
ISO 5832-12:1996
Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy |
ISO 5832-3:1996
Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
ISO 5832-4:1996
Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy |
ISO 5832-5:1993
Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel alloy |
ISO 5832-6:1997
Implants for surgery -- Metallic materials -- Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy |
ISO 5832-9:1992
Implants for surgery -- Metallic materials -- Part 9: Wrought high nitrogen stainless steel |
ISO 5834-2:1998
Implants for surgery -- Ultra-high molecular weight polyethylene -- Part 2: Moulded forms |
ISO 6474:1994
Implants for surgery -- Ceramic materials based on high purity alumina |
ISO 7153-1:1991
Surgical instruments -- Metallic materials -- Part 1: Stainless steel
ISO 7153-1:1991/Amd 1:1999 |
CAN/CSA-Z900.1-03: 2003-01-01
Cells, Tissues, and Organs for Transplantation and Assisted Reproduction: General Requirements |
| Ophthalmology |
ISO 10338:1996
Optics and optical instruments -- Contact lenses -- Determination of curvature |
ISO 10340:1995
Optics and optical instruments -- Contact lenses -- Method for determining the extractable substances |
ISO 10344:1996
Optics and optical instruments -- Contact lenses -- Saline solution for contact lens testing |
ISO 11979-2:1999
Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test methods
ISO 11979-2:1999/Cor 1:2003 |
ISO 11979-3:1999
Ophthalmic implants -- Intraocular lenses -- Part 3: Mechanical properties and test methods |
ISO 11979-5:1999
Ophthalmic implants -- Intraocular lenses -- Part 5: Biocompatibility |
ISO 11979-7:2006
Ophthalmic implants -- Intraocular lenses -- Part 7: Clinical Investigations |
ISO 11980:1997
Ophthalmic optics -- Contact lenses and contact lens care products -- Guidance for clinical investigations
ISO 11980:1997/Cor 1:1998 |
ISO 9339-1:1996
Optics and optical instruments -- Contact lenses -- Determination of the thickness -- Part 1: Rigid contact lenses |
ISO 9340:1996
Optics and optical instruments -- Contact lenses -- Determination of strains for rigid contact lenses |
ISO 9341:1996
Optics and optical instruments -- Contact lenses -- Determination of inclusions and surface imperfections for rigid contact lenses |
ISO 9913-1:1996
Optics and optical instruments -- Contact lenses -- Part 1: Determination of oxygen permeability and transmissibility with the FATT method |
| Orthopaedics |
ASTM F1044-05
Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings |
ASTM F1147-05
Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings |
ASTM F1160-05
Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings |
ASTM F1377-04
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) |
ASTM F1612-95(2000)
Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion |
ASTM F1659-95
Standard Test Method for Bending and Shear Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic Substrates |
ASTM F1798-97(2003)
Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
ASTM F1801-97 (2004)
Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials |
ASTM F746-04
Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials |
ASTM F86-04
Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
ASTM F983-86(2005)
Standard Practice for Permanent Marking of Orthopaedic Implant Components |
ISO 14630:2005
Non-active surgical implants -- General requirements |
ISO 5832-1:1997
Implants for surgery -- Metallic materials -- Part 1: Wrought stainless steel |
ISO 5832-2:1999
Implants for surgery -- Metallic materials -- Part 2: Unalloyed titanium |
ISO 5838-1:1995
Implants for surgery -- Skeletal pins and wires -- Part 1: Material and mechanical requirements |
ISO 5838-2:1991
Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions |
ISO 5838-3:1993
Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires |
ISO 7153-1:1991
Surgical instruments -- Metallic materials -- Part 1: Stainless steel
ISO 7153-1:1991/Amd 1:1999 |
ISO 7206-8:1995
Implants for surgery -- Partial and total hip joint prostheses -- Part 8: Endurance performance of stemmed femoral components with application of torsion |
ISO 9583:1993
Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgical implants |
| Radiology |
AIUM/NEMA UD 2-2004, Revision 3
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment |
AIUM/NEMA UD 3-2004, Revision 2
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment |
IEC 60601-2-37 - Consol. Ed. 1.1 (incl. am1) : 2004-10-14
Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment |
IEC 60601-1-3 - Ed. 1.0 : 1994-07-14
Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment |
IEC 60601-2-28 - Ed. 1.0 : 1993-03-07
Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis |
IEC 60601-2-32 - Ed. 1.0 : 1994-03-04
Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment |
IEC 60601-2-43 - Ed. 1.0 : 2000-06-30
Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures |
IEC 60601-2-44 - Consol. Ed. 2.1 (incl. am1) : 2002-11-15
Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography |
IEC 60601-2-7 - Ed. 2.0 : 1998-02-26
Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators |
| Sterilization |
ISO 11134:1994
Sterilization of health care products -- Requirements for validation and routine control -- Industrial moist heat sterilization |
CSA 11134-98 (R2003)
Sterilization of Health Care Products - Requirements for Validation and Routine Control - Industrial Moist Heat Sterilization |
ISO 11135:1994
Medical devices -- Validation and routine control of ethylene oxide sterilization
ISO 11135:1994/Cor 1:1994 |
CSA 11135-98 (R2003)
Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization |
ISO 11137:1995
Sterilization of health care products -- Requirements for validation and routine control -- Radiation sterilization |
CSA 11137-98 (R2003)
Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization |
ISO 11137:1995
Selection of items for dose setting
ISO 11137:1995/Cor 1:1997
ISO 11137:1995/Amd 1:2001 |
ISO 11138-1:1994
Sterilization of health care products -- Biological indicators -- Part 1: General |
ISO 11138-2:1994
Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization |
ISO 11138-3:1995
Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization |
ISO 11737-1:1995
Sterilization of medical devices -- Microbiological methods -- Part 1: Estimation of population of microorganisms on products |
STM F1980-02
Standard Guide for Accelerated Aging of Sterile Medical Device Packages |
