ANSI/AAMI/ISO 16142-2:2017
Current
Current
The latest, up-to-date edition.
MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
31-07-2017
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption
of ISO 16142-2:2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Essential principles of safety and performance
of IVD medical devices
5 Use of standards and guides in support
of the essential principles
6 Essential principles and references to
relevant standards and guides
Annex A (informative) - Rationale and guidance
Annex B (normative) - Table relating essential
principles to standards
Annex C (informative) - Website listings of other
standards suitable for the medical device
sector and for assessment purposes
Annex D (informative) - Reference to the essential
principles by International Standards
Annex E (informative) - Terminology - Alphabetized
index of defined terms
Bibliography
Covers the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended.
| Committee |
210
|
| DevelopmentNote |
Supersedes AAMI ISO TIR 16142. (08/2017)
|
| DocumentType |
Guide
|
| ISBN |
978-1-57020-671-9
|
| Pages |
56
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 16142-2:2017 | Identical |
| ISO/TS 13004:2013 | Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO/IEC 17000:2004 | Conformity assessment Vocabulary and general principles |
| CLSI MM3 A3 : 3ED 2015 | MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
| ISO 15195:2003 | Laboratory medicine Requirements for reference measurement laboratories |
| ISO 15194:2009 | In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation |
| ISO 22870:2016 | Point-of-care testing (POCT) — Requirements for quality and competence |
| ISO/TR 24971:2013 | Medical devices Guidance on the application of ISO 14971 |
| IEC TR 80001-2-5:2014 | Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems |
| EN 13641:2002 | Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
| ISO 15882:2008 | Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| IEC 61326-2-6:2012 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
| CLSI POCT4 A2 : 2ED 2006 | POINT-OF-CARE IN VITRO DIAGNOSTIC (IVD) TESTING |
| EN 13612:2002/AC:2002 | PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES |
| IEC 60812:2006 | Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| CLSI MM16 A : 1ED 2006 | USE OF EXTERNAL RNA CONTROLS IN GENE EXPRESSION ASSAYS |
| ISO 15193:2009 | In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement procedures |
| CLSI MM6 A2 : 2ED 2010 | QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES |
| CLSI EP5 A3 : 3ED 2014 | Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition<br> |
| CLSI MM9 A2 : 2ED 2014 | NUCLEIC ACID SEQUENCING METHODS IN DIAGNOSTIC LABORATORY MEDICINE |
| CLSI MM17 A : 1ED 2008 | VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS |
| ISO 31000:2009 | Risk management Principles and guidelines |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| CLSI EP26 A : 1ED 2013 | USER EVALUATION OF BETWEEN-REAGENT LOT VARIATION |
| EN 14136:2004 | Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| CLSI EP12 A2 : 2ED 2008 | USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE |
| ISO 25424:2009 | Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices |
| CLSI EP6 A : 1ED 2003 | EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH |
| ISO/TS 19218-1:2011 | Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes |
| ISO 18153:2003 | In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials |
| ISO/IEC Guide 63:2012 | Guide to the development and inclusion of safety aspects in International Standards for medical devices |
| ASTM F 2027 : 2016 : REDLINE | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| CLSI I/LA18 A2 : 2ED 2001 | SPECIFICATIONS FOR IMMUNOLOGICAL TESTING FOR INFECTIOUS DISEASES |
| CLSI MM22 A : 1ED 2014 | MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES |
| ISO 23640:2011 | In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents |
| ISO/IEC Guide 51:2014 | Safety aspects Guidelines for their inclusion in standards |
| ISO 17511:2003 | In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ASTM F 2761 : 2009 : R2013 | 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 |
| ISO 16256:2012 | Clinical laboratory testing and in vitro diagnostic test systems Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| EN 13532:2002 | General requirements for in vitro diagnostic medical devices for self-testing |
| CLSI POCT12 A3 : 3ED 2013 | Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition<br> |
| ISO 9001:2015 | Quality management systems — Requirements |
| IEC 62471:2006 | Photobiological safety of lamps and lamp systems |
| ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| ISO/IEC Guide 2:2004 | Standardization and related activities — General vocabulary |
| CLSI MM12 A : 1ED 2006 | DIAGNOSTIC NUCLEIC ACID MICROARRAYS |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| CLSI EP7 A2 : 2ED 2005 | INTERFERENCE TESTING IN CLINICAL CHEMISTRY |
| IEC TR 80001-2-1:2012 | 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 |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 15197:2013 | In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
| IEC 60601-1-9:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
| CLSI M53 A : 1ED 2011 | CRITERIA FOR LABORATORY TESTING AND DIAGNOSIS OF HUMAN IMMUNODEFICIENCY VIRUS INFECTION |
| IEC 60799:1998 | Electrical accessories - Cord sets and interconnection cord sets |
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