BS ISO 16142-2:2017
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
09-20-2017
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
Specifies the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic).
This document, which includes 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. This document identifies and describes the six general essential principles of safety and performance (see TableB.1) that apply to all medical devices, including IVD medical devices (in vitro diagnostic).
This document also identifies and describes the additional essential principles of safety and performance which need to be considered during the design and manufacturing process, which are relevant to IVD medical devices.
NOTE During the design process, the manufacturer selects which of the listed design and manufacturing principles apply to the particular medical device and documents the reasons for excluding others.
This document is intended for use as guidance by medical devicemanufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.
| Committee |
CH/210
|
| DevelopmentNote |
Supersedes 15/30328959 DC & 16/30346073 DC. (10/2017)
|
| DocumentType |
Standard
|
| Pages |
52
|
| PublisherName |
British Standards Institution
|
| 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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