|
ANSI Z80.27 : 2014
|
OPHTHALMICS - IMPLANTABLE GLAUCOMA DEVICES |
|
DIN EN ISO 12417-1 E : 2016
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
|
AAMI ST91 : 2015
|
FLEXIBLE AND SEMI-RIGID ENDOSCOPE PROCESSING IN HEALTH CARE FACILITIES |
|
AAMI SW87 : 2012
|
APPLICATION OF QUALITY MANAGEMENT SYSTEM CONCEPTS TO MEDICAL DEVICE DATA SYSTEMS |
|
ANSI INCITS 338 : 2003
|
HIGH-PERFORMANCE PARALLEL INTERFACE - 6400 MBIT/S OPTICAL SPECIFICATION (HIPPI-6400-OPT) |
|
AAMI ST65 : 2008 : R2013
|
PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
|
ISO/TR 27809:2007
|
Health informatics Measures for ensuring patient safety of health software |
|
ASTM F 2407 : 2006 : R2013 : EDT 1
|
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
|
PREN ISO 80601-2-61 : DRAFT 2009
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
|
DIN EN ISO 12417-1:2016-02
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
|
UNI EN ISO 80601-2-61 : 2011
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
|
13/30275206 DC : 0
|
BS ISO 5841-2 - IMPLANTS FOR SURGERY - CARDIAC PACEMAKERS - PART 2: REPORTING OF CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS OR LEADS |
|
ASTM F 2394 : 2007 : R2017
|
Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System |
|
BS EN 62148-17:2014
|
Fibre optic active components and devices. Package and interface standards Transmitter and receiver components with dual coaxial RF connectors |
|
AAMI TIR59:2017
|
INTEGRATING HUMAN FACTORS INTO DESIGN CONTROLS |
|
BS EN 61223-3-2:2008
|
Evaluation and routine testing in medical imaging departments Acceptance tests. Imaging performance of mammographic X-ray equipment |
|
ASTM F 2665 : 2009
|
Standard Specification for Total Ankle Replacement Prosthesis |
|
CSA Z9919 : 2007 : R2012
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
|
BS EN 62368-1 : 2014
|
AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS |
|
AAMI HE75 : 2009(R2013)
|
HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
|
ASTM F 2038 : 2000 : EDT 1
|
Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
|
CAN/CSA-Z900.2.1-17
|
Tissues for assisted reproduction |
|
CSA C22.2 No. 61010.1 : 2012 : INC : UPD 2 :2016
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
|
CAN/CSA-ISO/TS 16775:17
|
Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15) |
|
S.R. CEN ISO/TS 16775:2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014) |
|
ISO/TS 12417:2011
|
Cardiovascular implants and extracorporeal systems Vascular device-drug combination products |
|
AAMI ST65:2008(R2018)
|
PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
|
AAMI ST24 : 1999 : R2013
|
AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES |
|
AAMI AT6 : 2013
|
AUTOLOGOUS TRANSFUSION DEVICES |
|
BS EN ISO 80601-2-61:2011
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
|
ISO 18362:2016
|
Manufacture of cell-based health care products Control of microbial risks during processing |
|
ASTM F 1185 : 2003
|
Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
|
AAMI TIR38 : 2015
|
MEDICAL DEVICE SAFETY ASSURANCE CASE REPORT GUIDANCE |
|
ASTM G 175 : 2013 : REDLINE
|
Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Pressure Regulators Used for Medical and Emergency Applications |
|
ASTM E 2641 : 2009 : R2017
|
Standard Practice for Best Practices for Safe Application of 3D Imaging Technology |
|
AAMI ST41 : 2008
|
ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS |
|
CSA C22.2 No. 60601.2.43 : 2011
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
|
ASTM F 2038 : 2000
|
Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
|
ASTM F 1538 : 2003
|
Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation |
|
ASTM F 1185 : 2003 : R2014
|
Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
|
ASTM F 754 : 2008
|
Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders |
|
ASTM E 1000 : 2016 : REDLINE
|
Standard Guide for Radioscopy |
|
ASTM E 1741 : 2000
|
Standard Practice for Preparation of Airborne Particulate Lead Samples Collected During Abatement and Construction Activities for Subsequent Analysis by Atomic Spectrometry (Withdrawn 2009) |
|
ASTM D 5258 : 2002 : R2007
|
Standard Practice for Acid-Extraction of Elements from Sediments Using Closed Vessel Microwave Heating |
|
ASTM F 1538 : 2003 : R2009
|
Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation |
|
ASTM D 5258 : 2002 : R2013
|
Standard Practice for Acid-Extraction of Elements from Sediments Using Closed Vessel Microwave Heating |
|
ASTM F 3089 : 2014
|
Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions |
|
CSA C22.2 No. 61010.1 : 2012 : INC : UPD 1 :2015
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
|
ASTM E 94 : 2004 : R2010
|
Standard Guide for Radiographic Examination |
|
ASTM F 2900 : 2011
|
Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020) |
|
ASTM F 1925 : 2017 : REDLINE
|
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
|
ASTM E 1647 : 2016 : REDLINE
|
Standard Practice for Determining Contrast Sensitivity in Radiology |
|
NFPA 30 : 2018
|
FLAMMABLE AND COMBUSTIBLE LIQUIDS CODE |
|
CSA C22.2 No. 62368-1 : 2014
|
AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS |
|
BS EN ISO 14630:2012
|
Non-active surgical implants. General requirements |
|
IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV
|
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
|
I.S. EN 61223-2-6:2007
|
EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2-6: CONSTANCY TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT |
|
EN 62148-17:2014
|
Fiber optic active components and devices - Package and interface standards - Part 17: Transmitter and receiver components with dual coaxial RF connectors |
|
CEN ISO/TS 16775:2014
|
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014) |
|
AAMI TIR26 : 2000
|
VENTRICULAR ASSIST AND HEART REPLACEMENT SYSTEMS |
|
NSF 341 : 2012
|
HEALTH/FITNESS FACILITIES |
|
ISEA Z308.1 : 2015
|
MINIMUM REQUIREMENTS FOR WORKPLACE FIRST AID KITS AND SUPPLIES |
|
12/30251292 DC : 0
|
BS ISO/ASTM 51261 - PRACTICE FOR CALIBRATION OF ROUTINE DOSIMETRY SYSTEMS FOR RADIATION PROCESSING |
|
SAE ARP 5560 : 2014
|
SAFETY CONSIDERATIONS FOR HIGH-INTENSITY LIGHTS (HIL) DIRECTED INTO THE NAVIGABLE AIRSPACE |
|
ANSI/AAMI/IEC 60601-1-2:2014
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
|
14/30251609 DC : 0
|
BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
|
PD CEN ISO/TS 16775:2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
|
11/30246243 DC : 0
|
BS EN 62148-17 - FIBRE OPTIC ACTIVE COMPONENTS AND DEVICES - PACKAGE AND INTERFACE STANDARDS - PART 17: TRANSMITTER AND RECEIVER COMPONENTS WITH DUAL COAXIAL RF CONNECTORS |
|
DIN ISO 13022 E : 2014
|
MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012) |
|
AAMI TIR52 : 2014(R2017)
|
ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS |
|
BS EN 60601-2-44 : 2009
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009) |
|
ANSI Z80.11:2012
|
OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
|
ASTM F 3225 : 2017
|
Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs) |
|
ASTM F 1185 : 2003 : R2009
|
Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
|
ASTM F 1581 : 2008 : R2012
|
Standard Specification for Composition of Anorganic Bone for Surgical Implants |
|
CSA C22.2 No. 61010.1 : 2012 : INC : UPD 1 : 2015
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
|
ASTM F 882 : 1984 : R2002
|
Standard Performance and Safety Specification for Cryosurgical Medical Instruments (Withdrawn 2011) |
|
BS EN 60601-2-43:2010
|
Medical electrical equipment Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures |
|
ANSI/AAMI ST55:2016
|
TABLE-TOP STEAM STERILIZERS |
|
09/30181956 DC : DRAFT MAY 2009
|
BS ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
|
ASTM F 2042 : 2000 : R2005
|
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
|
AAMI ST67 : 2011
|
STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE' |
|
BS PAS 84(2008) : 2008
|
REGENERATIVE MEDICINE - GLOSSARY |
|
SAE AS 8056 : 2004(R2016)
|
MINIMUM DESIGN AND PERFORMANCE OF AIRPLANE GALLEY IN-FLIGHT CARTS, CONTAINERS, AND ASSOCIATED COMPONENTS |
|
AAMI TIR67 : 2018
|
PROMOTING SAFE PRACTICES PERTAINING TO THE USE OF STERILANT AND DISINFECTANT CHEMICALS IN HEALTH CARE FACILITIES |
|
AAMI ST72 : 2011 : R2016
|
BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING |
|
ASTM F 2042 : 2000 : EDT 1
|
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
|
ASTM F 1672 : 2014 : REDLINE
|
Standard Specification for Resurfacing Patellar Prosthesis |
|
ASTM F 2529 : 2013
|
Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) |
|
CSA C22.2 No. 61010.1 : 2012 : FR
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
|
ISO 5841-2:2014
|
Implants for surgery Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leads |
|
AAMI ST24 : 1999 : R2005
|
AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES |
|
AAMI TIR45 : 2012
|
GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE |
|
ARINC 805 : 2014
|
FIBER OPTIC TEST PROCEDURES |
|
ASTM F 881 : 1994 : R2000
|
Standard Specification for Silicone Elastomer Facial Implants |
|
AAMI TIR 12 : 2010
|
DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS |
|
ASTM F 2027 : 2016 : REDLINE
|
Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
|
UNE-EN ISO 18113-1:2012
|
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
|
ASTM E 2641 : 2009
|
Standard Practice for Best Practices for Safe Application of 3D Imaging Technology |
|
ASTM F 2150 : 2013 : REDLINE
|
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
|
ASTM F 2407 : 2006
|
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
|
ASTM F 2887 : 2017 : REDLINE
|
Standard Specification for Total Elbow Prostheses |
|
ASTM F 2224 : 2009 : R2014
|
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
|
ASTM F 2383 : 2011 : REDLINE
|
Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) |
|
ASTM F 754 : 2008 : R2015
|
Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders |
|
ASTM F 2394 : 2007 : R2013
|
Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System |
|
ASTM F 1609 : 2008 : R2014
|
Standard Specification for Calcium Phosphate Coatings for Implantable Materials |
|
ASTM F 1609 : 2008
|
Standard Specification for Calcium Phosphate Coatings for Implantable Materials |
|
ASTM F 1581 : 2008 : R2016
|
Standard Specification for Composition of Anorganic Bone for Surgical Implants |
|
IEC 60601-2-43:2010+AMD1:2017 CSV
|
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
|
ISO/TR 18112:2006
|
Clinical laboratory testing and in vitro diagnostic test systems In vitro diagnostic medical devices for professional use Summary of regulatory requirements for information supplied by the manufacturer |
|
NFPA 30 HDBK : 2018
|
FLAMMABLE AND COMBUSTIBLE LIQUIDS CODE HANDBOOK |
|
SCTE 186 : 2016
|
PRODUCT ENVIRONMENTAL REQUIREMENTS FOR CABLE TELECOMMUNICATIONS |
|
Z462-18
|
Workplace electrical safety |
|
ANSI/AAMI ST79:2017
|
COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
|
I.S. EN ISO 14630:2012
|
NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012) |
|
NEMA XR 31:2016
|
Standard Attributes on X-ray Equipment for Interventional Procedures |
|
NEMA/MITA 1:2015
|
Good Refurbishment Practices for Medical Imaging Equipment |
|
NFPA 1999 : 2018
|
PROTECTIVE CLOTHING AND ENSEMBLES FOR EMERGENCY MEDICAL OPERATIONS |
|
MIL-HDBK-516 Revision C:2014
|
AIRWORTHINESS CERTIFICATION CRITERIA |
|
SAE ARP 5293 : 2010
|
SAFETY CONSIDERATIONS FOR LASERS PROJECTED IN THE NAVIGABLE AIRSPACE |
|
I.S. EN ISO 9919:2009
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
|
DD ISO/TS 12417:2011
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS |
|
AAMI TIR36 : 2007
|
VALIDATION OF SOFTWARE FOR REGULATED PROCESSES |
|
AAMI TIR72 : 2017
|
DIALYSIS FLUID CHEMICAL COMPOSITION |
|
ANSI/AAMI EQ56:2013
|
RECOMMENDED PRACTICES FOR A MEDICAL EQUIPMENT MANAGEMENT PROGRAM |
|
ANSI/AAMI NS4:2013(R2017)
|
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS |
|
AAMI ST24 : 1999 : R2009
|
AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES |
|
BS EN ISO 12417-1:2015
|
Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements |
|
ASTM F 2312 : 2011 : REDLINE
|
Standard Terminology Relating to Tissue Engineered Medical Products |
|
CSA C22.2 No. 61010.1 :2012
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
|
ANSI/AAMI EQ89:2015
|
GUIDANCE FOR THE USE OF MEDICAL EQUIPMENT MAINTENANCE STRATEGIES AND PROCEDURES |
|
AAMI ST72 : 2011
|
BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING |
|
AAMI TIR50 : 2014
|
POST-MARKET SURVEILLANCE OF USE ERROR MANAGEMENT |
|
CSA Z9919 :2007
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
|
DIN ISO 13022:2014-06
|
MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012) |
|
SAE ARP 5873 : 2015
|
LED PASSENGER READING LIGHT ASSEMBLY |
|
AAMI ISO 5841-2 : 2014
|
IMPLANTS FOR SURGERY - CARDIAC PACEMAKERS - PART 2: REPORTING OF CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS OR LEADS |
|
ANSI/AAMI PB70:2012
|
LIQUID BARRIER PERFORMANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CARE FACILITIES |
|
AAMI TIR48 : 2015
|
QUALITY MANAGEMENT SYSTEM (QMS) RECOMMENDATIONS ON THE APPLICATION OF THE U.S. FDAS CGMP FINAL RULE ON COMBINATION PRODUCTS |
|
AAMI ST65 : 2008
|
PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
|
AAMI ST24:1999(R2018)
|
AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES |
|
CEN/TR 15640:2007
|
Health informatics - Measures for ensuring the patient safety of health software |
|
EN 60601-2-43:2010/A1:2018
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES (IEC 60601-2-43:2010/A1:2017) |
|
ASTM E 2981 : 2015
|
Standard Guide for Nondestructive Testing of the Composite Overwraps in Filament Wound Pressure Vessels Used in Aerospace Applications |
|
ASTM D 5258 : 2002
|
Standard Practice for Acid-Extraction of Elements from Sediments Using Closed Vessel Microwave Heating |
|
SAE ARP 5674 : 2012
|
SAFETY CONSIDERATIONS FOR AIRCRAFT-MOUNTED LASERS PROJECTED INTO THE NAVIGABLE AIRSPACE |
|
ASTM F 2903 : 2011
|
Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020) |
|
ASTM F 2212 : 2011 : REDLINE
|
Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
|
ASTM E 2662 : 2015 : REDLINE
|
Standard Practice for Radiographic Examination of Flat Panel Composites and Sandwich Core Materials Used in Aerospace Applications |
|
ASTM F 881 : 1994 : R2006
|
Standard Specification for Silicone Elastomer Facial Implants |
|
ASTM E 94 : 2004
|
Standard Guide for Radiographic Examination |
|
CAN/CSA-C22.2 NO. 61010-1-12 (R2017)
|
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements (Tri-national standard, with UL 61010-1 and ANSI/ISA-61010-1 (82.02.01) |
|
ASTM F 2042 : 2000 : R2011
|
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication |
|
EN ISO 80601-2-61:2011
|
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011) |
|
I.S. EN 61223-3-2:2008
|
EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-2: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT |
|
IEC 62368-1:2014
|
Audio/video, information and communication technology equipment - Part 1: Safety requirements |
|
BS EN ISO 9919:2009
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
|
IEC 61223-3-2:2007
|
Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
|
CSA C22.2 No. 60950-1 :2007
|
INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS |
|
CSA C22.2 No. 60950-1 : 2007 : INC : AMD 1 : 2011 : R2012
|
INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS |
|
ISA 61010-1 : 2008
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
|
NASA STD 8719.24 : 2011
|
NASA EXPENDABLE LAUNCH VEHICLE PAYLOAD SAFETY REQUIREMENTS |
|
CSA C22.2 No. 60950-1 : 2007 : INC : AMD 2 : 2014 : R201200
|
INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS |
|
CSA C22.2 No. 60950-1 : 2007 : R2012
|
INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS |
|
CSA C22.2 No. 60950-1 : 2007 : INC : UPD 1 : 2011
|
INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS |
|
CSA C22.2 No. 60950-1 : 2007 : INC : AMD 2 : 2014 : R2016
|
INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS |
|
MIL-HDBK-454 Revision B:2007
|
GENERAL GUIDELINES FOR ELECTRONIC EQUIPMENT |
|
EN ISO 18113-1:2011
|
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
|
EN ISO 9919:2009
|
Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) |
|
UNI EN ISO 14630 : 2013
|
NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
|
NSF T-BUTANOL : 2003
|
T-BUTANOL |
|
ASTM F 2394 : 2007
|
Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System |
|
UNE-EN 60601-2-44:2010
|
Medical electrical equipment -- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
|
BS ISO 5841-2:2014
|
IMPLANTS FOR SURGERY - CARDIAC PACEMAKERS - PART 2: REPORTING OF CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS OR LEADS |
|
CLSI MM14 A : 1ED 2005
|
PROFICIENCY TESTING (EXTERNAL QUALITY ASSESSMENT) FOR MOLECULAR METHODS |
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12/30239867 DC : 0
|
BS EN 62368-1 - AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS |
|
PD ISO/TR 27809:2007
|
Health informatics. Measures for ensuring patient safety of health software |
|
AAMI BF64 : 2012
|
LEUKOCYTE REDUCTION FILTERS |
|
PD IEC/PAS 63077:2016
|
GOOD REFURBISHMENT PRACTICES FOR MEDICAL IMAGING EQUIPMENT |
|
DI-TCSP-82040 Base Document:2016
|
RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) |
|
ANSI N42.46 : 2008
|
DETERMINATION OF THE IMAGING PERFORMANCE OF X-RAY AND GAMMA-RAY SYSTEMS FOR CARGO AND VEHICLE SECURITY SCREENING |
|
PD CEN/TR 15640:2007
|
HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE |
|
AAMI TIR14 : 2016
|
CONTRACT STERILIZATION USING ETHYLENE OXIDE |
|
BS ISO 18190:2016
|
Anaesthetic and respiratory equipment. General requirements for airways and related equipment |
|
MIL-HDBK-828 Revision C:2017
|
RANGE LASER SAFETY |
|
AAMI NS4 :2013
|
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS |
|
I.S. EN ISO 18113-1:2011
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
|
I.S. EN 62148-17:2014
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FIBER OPTIC ACTIVE COMPONENTS AND DEVICES - PACKAGE AND INTERFACE STANDARDS - PART 17: TRANSMITTER AND RECEIVER COMPONENTS WITH DUAL COAXIAL RF CONNECTORS |
|
AAMI ST67 : 2011 : R2017
|
STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE' |
|
AAMI TIR55 : 2014
|
HUMAN FACTORS ENGINEERING FOR PROCESSING MEDICAL DEVICES |
|
AAMI TIR52 : 2014
|
ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS |
|
UNE-EN ISO 12417-1:2016
|
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
|
ISO/TR 12417-2:2017
|
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information |
|
ASTM D 5765 : 2016 : REDLINE
|
Standard Practice for Solvent Extraction of Total Petroleum Hydrocarbons from Soils and Sediments Using Closed Vessel Microwave Heating |
|
AAMI TIR69 : 2017
|
RISK MANAGEMENT OF RADIO-FREQUENCY WIRELESS COEXISTENCE FOR MEDICAL DEVICES AND SYSTEMS |
|
AAMI ISO 12417-1 : 2015
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
|
ANSI Z80.11 : 2012 : R2017
|
OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
|
SCTE 203 : 2014
|
PRODUCT ENVIRONMENTAL REQUIREMENTS FOR CABLE TELECOMMUNICATIONS FACILITIES - TEST METHODS |
|
ASTM F 2038 : 2000 : R2005
|
Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
|
NFPA 1582 : 2018
|
COMPREHENSIVE OCCUPATIONAL MEDICAL PROGRAM FOR FIRE DEPARTMENTS |
|
IEEE 730-2014
|
SOFTWARE QUALITY ASSURANCE PROCESSES |
|
ANSI/AAMI/ISO TIR16775:2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
|
I.S. EN 62368-1:2014
|
AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS (IEC 62368-1:2014, MODIFIED) |
|
FAA AC 25-10 : 0
|
GUIDANCE FOR INSTALLATION OF MISCELLANEOUS, NON-REQUIRED ELECTRICAL EQUIPMENT |
|
EN 62368-1:2014/AC:2017-03
|
AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS (IEC 62368-1:2014, MODIFIED) |
|
ASTM F 881 : 1994 : R2014
|
Standard Specification for Silicone Elastomer Facial Implants |
|
ASTM F 2038 : 2000 : R2011
|
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials |
|
ASTM F 1781 : 2015 : REDLINE
|
Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants |
|
ASTM F 2665 : 2009 : R2014
|
Standard Specification for Total Ankle Replacement Prosthesis |
|
ASTM F 2042 : 2000
|
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
|
ISO 13022:2012
|
Medical products containing viable human cells — Application of risk management and requirements for processing practices |
|
ISO/ASTM 51261:2013
|
Practice for calibration of routine dosimetry systems for radiation processing |
|
I.S. EN 60601-2-43:2010
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
|
I.S. EN 60601-2-44:2009
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY |
|
EN 60601-2-44:2009/A2:2016
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009/A2:2016) |
|
DIN EN ISO 14630:2013-03
|
Non-active surgical implants - General requirements (ISO 14630:2012) |
|
ISO/TS 16775:2014
|
Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
|
IEC 61223-2-6:2006
|
Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests imaging performance of computed tomography X-ray equipment |
|
CAN/CSA-C22.2 No. 62841-1 : 2015
|
ELECTRIC MOTOR-OPERATED HAND-HELD TOOLS, TRANSPORTABLE TOOLS AND LAWN AND GARDEN MACHINERY - SAFETY - PART 1: GENERAL REQUIREMENTS |
|
IEC 62148-17:2013
|
Fibre optic active components and devices - Package and interface standards - Part 17: Transmitter and receiver components with dual coaxial RF connectors |
|
IEC 60601-1-2:2007
|
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests |
|
ISO 18113-1:2009
|
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
|
ISO 12417-1:2015
|
Cardiovascular implants and extracorporeal systems Vascular device-drug combination products Part 1: General requirements |
|
BS EN 61223-2-6:2007
|
Evaluation and routine testing in medical imaging departments Constancy tests. Imaging performance of computed tomography X-ray equipment |
|
UNI CEN ISO/TS 16775 : 2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
|
EN ISO 14630:2012
|
Non-active surgical implants - General requirements (ISO 14630:2012) |
|
EN ISO 12417-1:2015
|
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
|
I.S. EN ISO 80601-2-61:2011
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
|
AAMI ISO TIR 12417 : 2011
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS |
|
ASTM E 2941 : 2014 : REDLINE
|
Standard Practices for Extraction of Elements from Ores and Related Metallurgical Materials by Acid Digestion |
|
CSA C22.2 No. 80601-2-61 : 2014(R2019)
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
|
FAA AC 20-183 : 2014
|
LASER AIRWORTHINESS INSTALLATION GUIDANCE |
|
AAMI TIR16 : 2017
|
MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION |
|
ASTM F 1441 : 2003
|
Standard Specification for Soft-Tissue Expander Devices |
|
S.R. CEN TR 15640:2007
|
HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE |
|
10/30203224 DC : 0
|
BS ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES |
|
BS ISO 18362:2016
|
Manufacture of cell-based health care products. Control of microbial risks during processing |
|
DIN EN ISO 18113-1:2013-01
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
|
BS EN ISO 18113-1:2011
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
|
SAE ARP 6253 : 2017
|
LEDS AND AIRCRAFT APPLICATIONS |
|
NFPA 115 : 2016
|
LASER FIRE PROTECTION |
|
ANSI/AAMI ST58:2013(R2018)
|
CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES |
|
ANSI/AAMI ST90:2017
|
PROCESSING OF HEALTH CARE PRODUCTS - QUALITY MANAGEMENT SYSTEMS FOR PROCESSING IN HEALTH CARE FACILITIES |
|
ANSI N42.44 : 2008
|
PERFORMANCE OF CHECKPOINT CABINET X-RAY IMAGING SECURITY SYSTEMS |
|
AAMI TIR37 : 2013
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS |
|
ANSI/AAMI/ISO 13022:2012
|
MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES |
|
FAA AC 70-1 : 2004
|
OUTDOOR LASER OPERATIONS |
|
07/30166162 DC : 0
|
BS IEC 60601-2-44 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY |
|
ASTM E 94/E94M : 2017 : REDLINE
|
Standard Guide for Radiographic Examination Using Industrial Radiographic Film |
|
AAMI TIR15 : 2016
|
PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION |
|
C22.2 NO. 243-17
|
Vacuum cleaners, blower cleaners, and household floor finishing machines (Binational standard with UL 1017) |
|
AAMI HE75 : 2009
|
HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
|
AAMI QSR : 1996
|
QUALITY SYSTEM REGULATION (21 CFR PARTS 808, 812 AND 820) - OCTOBER 1996 |
|
ISO 18190:2016
|
Anaesthetic and respiratory equipment — General requirements for airways and related equipment |
|
ASTM F 2091 : 2015 : REDLINE
|
Standard Specification for Acetabular Prostheses |
|
I.S. EN ISO 12417-1:2015
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
|
UNI EN ISO 18113-1 : 2012
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
|
ASTM E 1570 : 2011 : REDLINE
|
PRACTICE FOR COMPUTED TOMOGRAPHIC (CT) EXAMINATION |
|
SAE ARP 6161 : 2011
|
FLIGHT COMPARTMENT GLARE |
|
CAN/CSA C22.2 No. 60601.2.43 : 2011(R2016)
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES |
|
ASTM F 1441 : 2003 : R2009
|
Standard Specification for Soft-Tissue Expander Devices |
|
ASTM F 1538 : 2003 : R2017
|
Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation |
|
ASTM E 2698 : 2010
|
Standard Practice for Radiological Examination Using Digital Detector Arrays |
|
ASTM E 2982 : 2014
|
Standard Guide for Nondestructive Testing of Thin-Walled Metallic Liners in Filament-Wound Pressure Vessels Used in Aerospace Applications |
|
ASTM F 1581 : 2008 : EDT 1
|
Standard Specification for Composition of Anorganic Bone for Surgical Implants |
|
ASTM F 1538 : 2003 : EDT 1
|
Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation |
|
ASTM E 1255 : 2016 : REDLINE
|
Standard Practice for Radioscopy |
|
ASTM F 1441 : 2003 : R2014
|
Standard Specification for Soft-Tissue Expander Devices |
|
CSA C22.2 No. 61010.1 : 2012 : INC : UPD 2 : 2016
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
|
ASTM F 2224 : 2009
|
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
|
ASTM F 1581:2008
|
Standard Specification for Composition of Anorganic Bone for Surgical Implants |
|
ASTM F 2211 : 2013
|
Standard Classification for Tissue Engineered Medical Products (TEMPs) |
|
ASTM F 2083 : 2012 : REDLINE
|
Standard Specification for Knee Replacement Prosthesis |
|
ISO 9919:2005
|
Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
|
ISO 14630:2012
|
Non-active surgical implants General requirements |
|
EN 61223-2-6:2007
|
Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment |
|
EN 61223-3-2:2008
|
Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |