Name: DIN EN ISO 15883-7 E : 2016
Brand: DIN

WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)

Published date

24-10-2016

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword National Annex NA (informative) - Bibliography European foreword Annex ZA (informative) - Relationship between this          European Standard and the essential requirements          of Directive 93/42/EEC [OJ L 169] aimed to be covered Foreword Introduction 1 Scope 2 Normative references 3 Terms and definitions 4 Performance requirements 5 Mechanical requirements 6 Testing for conformity 7 Documentation 8 Information to be provided by the manufacturer 9 Marking, labelling, and packaging 10 Information to be requested from the purchaser    by the manufacturer Annex A (normative) - Summary of test programmes Annex B (normative) - Methods for microbiological evaluation         of disinfection of liquid transport system Annex C (normative) - Tests for microbiological contamination         of post-disinfection rinse water Annex D (normative) - Preparation and evaluation of indicators         for microbiological testing of the efficacy of chemical         disinfection of the load Annex E (informative) - Examples of test locations for the tests with         biological indicators Bibliography

Describes the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as the following: a) bedframes; b) bedside tables; c) transport carts; d) containers; e) surgical tables; f) sterilization containers; g) surgical clogs; h) wheelchairs, aids for the disabled.

DocumentType	Standard
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

Standards	Relationship
ISO 15883-7:2016	Identical
EN ISO 15883-7:2016	Identical

EN ISO 11737-2:2009	Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
IEC 61010-2-040:2015	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
EN 13624:2013	Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
ISO 15883-1:2006	Washer-disinfectors Part 1: General requirements, terms and definitions and tests
EN ISO 15883-3:2009	Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
EN 61010-2-040:2015	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
VDE 0411-2-040 : 2016	SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS (IEC 61010-2-040:2015)
DIN ISO/TS 15883-5:2006-02	Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005); German version CEN ISO/TS 15883-5:2005
ISO 11737-1:2006	Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 15883-6:2011	Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
ISO 15883-3:2006	Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
CEN ISO/TS 15883-5:2005	Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
EN 14348:2005	Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)
EN 10088-2:2014	STAINLESS STEELS - PART 2: TECHNICAL DELIVERY CONDITIONS FOR SHEET/PLATE AND STRIP OF CORROSION RESISTING STEELS FOR GENERAL PURPOSES
EN ISO 15883-4:2009	Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
EN 13727:2012+A2:2015	Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)
EN ISO 15883-6:2015	Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
ISO/TS 15883-5:2005	Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
ISO 15883-4:2008	Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
EN ISO 15883-1:2009/A1:2014	WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006/AMD 1:2014)
EN 14476:2013+A1:2015	Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
EN 1040:2005	Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
ISO 15883-2:2006	Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
EN ISO 15883-2:2009	Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)
DIN EN 61010-2-040 : 2016	SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS (IEC 61010-2-040:2015)
EN 10088-1:2014	Stainless steels - Part 1: List of stainless steels