• There are no items in your cart

BS ISO 16142-2:2017

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Medical devices. Recognized essential principles of safety and performance of medical devices 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

Withdrawn date

03-07-2024

Language(s)

English

Published date

20-09-2017

€303.84
Excluding VAT

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).

Committee
CH/210
DevelopmentNote
Supersedes 15/30328959 DC & 16/30346073 DC. (10/2017)
DocumentType
Standard
Pages
52
PublisherName
British Standards Institution
Status
Withdrawn
Supersedes

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.

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
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

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.