Standards on CD Subscribers Area
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Standards Available for Download:
- ANSI/AAMI ST8:2013, Hospital steam sterilizers (April 2013)
- ANSI/AAMI BF7:2012 Blood transfusion micro-filters (April 2013)
- ANSI/AAMI BF64:2012 Leukocyte reduction filters (April 2013)
- ANSI/AAMI ST77:2013 Containment devices for reusable medical device sterilization (April 2013)
- AAMI TIR49:2013 Design of training and instructional materials for medical devices used in non-clinical environments (April 2013)
- ANSI/AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms (April 2013)
- ANSI/AAMI/ISO 25539-2:2012 Cardiovascular implants — Endovascular devices — Part 2: Vascular stents (April 2013)
- ANSI/AAMI EQ56:2013 Recommended practice for a medical equipment management program (Mar 2013)
- ANSI/AAMI/ ST15883-2: 2013 (ISO 15883-2:2006, MOD) Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (Mar 2013)
- ANSI/AAMI/ST15883-3: 2012 (ISO 15883-3:2006, MOD) Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (Mar 2013)
- 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) (Mar 2013)
- AAMI TIR29:2012 Technical Information Report Guide for process characterization and control in radiation sterilization of medical devices (Feb 2013)
- ANSI/AAMI/IEC TIR 62348:2012 Technical Information Report Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition (Feb 2013)
- ANSI/AAMI/ISO TIR 15499:2012 Technical Information Report Biological evaluation of medical devices–Guidance on the conduct of biological evaluation within a risk management process (Feb 2013)
- ANSI/AAMI ST41:2008/(R)2012 Ethylene oxide sterilization in health care facilities: Safety and effectiveness (Feb 2013)
- ANSI/AAMI/ISO 10993-17:2002/(R)2012 Biological evaluation of medical devices — Part 17: Methods for the establishment of allowable limits for leachable substances (Feb2013)
- ANSI/AAMI/ISO 13408-3:2006/(R)2012 Aseptic processing of health care products — Part 3: Lyophilization (Feb 2013)
- ANSI/AAMI/ISO 13408-4-2005/(R)2012 Aseptic processing of health care products - Part 4: Clean-in-place technologies (Feb 2013)
- ANSI/AAMI/ISO 13408-5-2006/(R)2012 Aseptic processing of health care products - Part 5: Sterilization in place (Feb 2013)
- ANSI/AAMI ST15883-1:2009 Washer-disinfectors — Part 1: General requirements, terms and definitions and tests, Amendment 2 (Dec 2012)
- ANSI/AAMI/ISO 14117: 2012 Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices (Dec 2012)
- ANSI/AAMI/ISO TIR 19218-2:2012 Technical Information Report Medical devices — Hierarchal coding structure for adverse events — Part 2: Evaluation codes (Dec 2012)
- ANSI/AAMI/IEC TIR80001-2-2:2012 Technical Information Report Application of risk management for IT networks incorporating medical devices — Part 2-2: Guidance for the disclosure and communication of medical device security (Nov 2012)
- ANSI/AAMI ES60601-1 :2005/ Amendments Medical electrical equipment — Part 1: General requirements for basic safety and essential performance, Amendments (Nov 2012)
- ANSI/AAMI/IEC 60601-2-16:2012 Medical electrical equipment — Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment (Nov 2012)
- ANSI/AAMI/ISO 15223-1:2012 Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: General requirements (Nov 2012)
- ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Oct 2012)
- ANSI/AAMI/IEC TIR80001-2-1:2012 Technical Information Report Application of risk management for IT-networks incorporating medical devices — Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples (Oct 2012)
- ANSI/AAMI/IEC TIR80001-2-3:2012 Technical Information Report Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks (Oct 2012)
- ANSI/AAMI/ ISO 11658:2012 Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems (Oct 2012)
- ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Oct 2012)
- ANSI/AAMI ST79:2010/A3:2012, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Amendment 3 (Created in track changes so you can see what changed.) (Oct 2012)
- ANSI/AAMI/ISO 13408-7:2012 Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products (Sep 2012)
- ANSI/AAMI/ISO 10993-12:2012 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (Sep 2012)
- AAMI TIR45: 2012 Technical Information Report Guidance on the use of AGILE practices in the development of medical device software (Sep 2012)
Anything above this point was added after the 2012.2 version was issued.
- ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (August 2012)
- ANSI/AAMI/IEC 60601-2-47:2012 Medical electrical equipment — Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems (August 2012)
- ANSI/AAMI/ISO 11140-3:2007/(R)2012 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (August 2012)
- ANSI/AAMI/ ISO 11140-4:2007/(R)2012 Sterilization of Health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration (August 2012)
- ANSI/AAMI/ISO 11140-5:2007/(R)2012 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs (August 2012)
- ANSI/AAMI/ ISO 25539-3: 2011 Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters (August 2012)
- ANSI/AAMI/ ISO TIR23810: 2012 Technical Information Report Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup (August 2012)
- ANSI/AAMI/ ISO 11137-2: 2012 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (August 2012)
- ANSI/AAMI/IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs (July 2012)
- ANSI/AAMI/ISO 13022:2012 Medical products containing viable human cells — Application of risk management and requirements for processing practices (July 2012)
- ANSI/AAMI/ISO 10993-7: 2008/(R)2012 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (July 2012)
- ANSI/AAMI/ IEC 60601- 2-27:2011 Medical electrical equipment — Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (June 2012)
- ANSI/AAMI SW87:2012 Application of quality management system concepts to medical device data systems (June 2012)
- ANSI/AAMI/ IEC TIR 61289:2011 Technical Information Report High frequency surgical equipment – Operation and maintenance (April 2012)
- ANSI/AAMI/ ISO 27185: 2012 Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements (April 2012)
- ANSI/AAMI/IEC 60601-2-19:2009, Medical electrical equipment - Part 2-19: Particular requirements for basic safety and essential performance of baby incubators (April 2012)
- ANSI/AAMI/IEC 60601-2-20:2009, Medical electrical equipment - Part 2-20: Particular requirements for basic safety and essential performance of transport incubators (April 2012)
- ANSI/AAMI/ISO 7199:2009 Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) Amendment 1 (April 2012)
- ANSI/AAMI/ ISO 7199: 2009 & A1: 2012 Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) (April 2012)
Anything above this point was added after the 2012.1 version was issued.
- ANSI/AAMI ISO 14160:2011 Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (Feb 2012)
- AAMI TIR41:
2011 Technical
Information
Report
Active implantable medical devices –
Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators (Feb 2012) - ANSI/AAMI/ ISO 15223-1: 2007/(R)2012 and A1:2008/ (R)2012 Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements (Jan 2012)
- 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 (Jan 2012)
- ANSI/AAMI ID54:1996/ (R)2012 Enteral feeding set adapters and connectors (Jan 2012)
- 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). (Jan 2012)
- ANSI/AAMI BP22:1994/ (R)2011 Blood pressure transducers (Jan 2012)
- ANSI/AAMI/ ISO 13408- 1:2008/ (R)2011 Aseptic processing of health care products — Part 1: General requirements (Jan 2012)
- ANSI/AAMI ST72:2011 Bacterial endotoxins — Test methods, routine monitoring, and alternatives to batch testing Red-line Format (Jan 2012)
- ANSI/AAMI ST72:2011 Bacterial endotoxins — Test methods, routine monitoring, and alternatives to batch testing (Jan 2012)
- AAMI TIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices Red-line Format (Jan 2012)
- ANSI/AAMI/ ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice (Jan 2012)
- 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) (Dec 2011)
- ANSI/AAMI/ISO 10993-14:2001/(R)2011 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics (Dec 2011)
- ANSI/AAMI/ISO 10993-15:2000/(R)2011 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (Dec 2011)
- ANSI/AAMI/ISO 11737-1:2006/(R)2011Sterilization of health care products— Microbiological methods—Part 1: Determination of the population of microorganisms on product (Dec 2011)
- ANSI/AAMI/ISO 14708-3:2008/(R)2011 Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators (Dec 2011)
- ANSI/AAMI/ISO 14708-4:2008/(R)2011 Implants for surgery—Active implantable medical devices—Part 4: Implantable infusion pumps (Dec 2011)
- ANSI/AAMI/ISO 22442-1:2007/(R)2011 Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management (Dec 2011)
- ANSI/AAMI/ISO 22442-2:2007/(R)2011 Medical devices utilizing animal tissues and their
derivatives — Part 2: Controls on sourcing, collection and handling (Dec 2011) - ANSI/AAMI/ISO 22442-3:2007/(R)2011 Medical devices utilizing animal tissues and their
derivatives—Part 3: Validation of the elimination and/ or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (Dec 2011) - ANSI/AAMI BF7:1989/ (R)2011 Blood transfusion microfilters (Dec 2011)
- ANSI/AAMI BF64:2002/(R)2011 Leukocyte reduction filters (Dec 2011)
- ANSI/AAMI BE83:2006/(R)2011 Biological evaluation of medical devices—Part 18: Chemical characterization of materials (Dec 2011)
- ANSI/AAMI/ ISO TIR 19218-1:2011 Medical devices — Hierarchal coding structure for adverse events — Part 1: Event-type codes (Nov 2011)
- ANSI/AAMI/ISO TIR 22442-4: 2010 Medical devices utilizing animal tissues and their derivatives — Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes (Nov 2011)
- AAMI TIR43: 2011 Ultrapure dialysate for hemodialysis and related therapies (Nov 2011)
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