• BS EN ISO 21649:2009 (published 2009-11)

    Current The latest, up-to-date edition.

    Needle-free injectors for medical use. Requirements and test methods

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-11-2009

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Symbols and abbreviated terms
    5 Requirements
    6 Test methods
    7 Test report
    8 Information supplied by the manufacturer
    Annex A (informative) - Two-sided tolerance limit
                            factors (k)
    Annex B (informative) - Examples of accuracy limit
                            calculations and random settings
    Annex C (informative) - Correspondence between ISO/IEC
                            standards and EN standards
    Annex ZA (informative) - Relationship between this
                             International Standard and
                             the Essential Requirements
                             of EU Directive 93/42/EEC
    Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients.

    General Product Information - (Show below) - (Hide below)

    Committee CH/84
    Development Note Supersedes 03/113382 DC (06/2006)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 11202:2010 Acoustics Noise emitted by machinery and equipment Determination of emission sound pressure levels at a work station and at other specified positions applying approximate environmental corrections
    EN ISO 11204:2010 Acoustics - Noise emitted by machinery and equipment - Determination of emission sound pressure levels at a work station and at other specified positions applying accurate environmental corrections (ISO 11204:2010)
    IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    IEC 61000-4-1:2006 Electromagnetic compatibility (EMC) - Part 4-1: Testing and measurement techniques - Overview of IEC 61000-4 series
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    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
    ISO 14253-1:2017 Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for verifying conformity or nonconformity with specifications
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    IEC 60721-3-7:1995+AMD1:1996 CSV Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
    EN 60068-2-64:2008 ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
    EN 61000-4-2:2009 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-2: TESTING AND MEASUREMENT TECHNIQUES - ELECTROSTATIC DISCHARGE IMMUNITY TEST
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    EN 60721-3-7:1995/A1:1997 CLASSIFICATION OF ENVIRONMENTAL CONDITIONS - PART 3: CLASSIFICATION OF GROUPS OF ENVIRONMENTAL PARAMETERS AND THEIR SEVERITIES - SECTION 7: PORTABLE AND NON-STATIONARY USE
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    EN 61000-4-3 : 2006 AMD 2 2010 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST
    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
    ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
    EN ISO 11201:2010 Acoustics - Noise emitted by machinery and equipment - Determination of emission sound pressure levels at a work station and at other specified positions in an essentially free field over a reflecting plane with negligible environmental corrections (ISO 11201:2010)
    EN 60068-2-27:2009 ENVIRONMENTAL TESTING - PART 2-27: TESTS - TEST EA AND GUIDANCE: SHOCK
    ISO 3746:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
    EN 61672-1:2013 ELECTROACOUSTICS - SOUND LEVEL METERS - PART 1: SPECIFICATIONS (IEC 61672-1:2013)
    IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 9000:2015 Quality management systems Fundamentals and vocabulary
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    EN 60068-2-30:2005 ENVIRONMENTAL TESTING - PART 2-30: TESTS - TEST DB: DAMP HEAT, CYCLIC (12 H + 12 H CYCLE)
    EN 60068-2-32 : 1993 BASIC ENVIRONMENTAL TESTING PROCEDURES - PART 2: TESTS - TEST ED: FREE FALL
    EN ISO 14155-2 : 2009 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
    EN ISO 14155-1 : 2009 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    EN ISO 11202:2010 Acoustics - Noise emitted by machinery and equipment - Determination of emission sound pressure levels at a work station and at other specified positions applying approximate environmental corrections (ISO 11202:2010)
    ISO 11201:2010 Acoustics Noise emitted by machinery and equipment Determination of emission sound pressure levels at a work station and at other specified positions in an essentially free field over a reflecting plane with negligible environmental corrections
    ISO 11204:2010 Acoustics Noise emitted by machinery and equipment Determination of emission sound pressure levels at a work station and at other specified positions applying accurate environmental corrections
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
    IEC 60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)
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