BS EN ISO 15883-4 - WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Mechanical and process requirements
6 Testing for conformity
7 Documentation and inspection
8 Information to be supplied by the manufacturer
9 Marketing, labelling and packaging
10 Information to be requested from the purchaser
   by the manufacturer
Annex A (informative) - Summary of activities covered
        by this part of ISO 15883
Annex B (normative) - Microbiological testing of the efficacy
        of chemical disinfection of the load
Annex C (normative) - Summary of test programmes
Annex D (normative) - Methods for microbiological
        evaluation of disinfection of liquid transport system
Annex E (normative) - Tests for microbial contamination
        of post-disinfection rinse water
Annex F (informative) - Additional notes on microbiological
        testing of chemical disinfection processes
Annex G (informative) - Typical specifications of trumpet
        valves and connection ports
Annex H (normative) - Establishing endoscope type test groups
Annex I (informative) - Establishing endoscope product families
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         93/42/EEC on medical devices
Bibliography

BS EN ISO 15883-4.

Committee	CH/198
DocumentType	Draft
Pages	90
PublisherName	British Standards Institution
Status	NA
Supersedes	BS EN ISO 15883-4:2018

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
ISO 11737-1:2006	Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
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)
ISO 11731-2:2004	Water quality Detection and enumeration of Legionella Part 2: Direct membrane filtration method for waters with low bacterial counts
ISO 384:2015	Laboratory glass and plastics ware Principles of design and construction of volumetric instruments
EN 12353:2013	Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
ISO/TS 15883-5:2005	Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
EN 14562 : 2006	CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF FUNGICIDAL OR YEASTICIDAL ACTIVITY FOR INSTRUMENTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)
ASTM E 1053 : 2011 : REDLINE	Standard Test Method to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces
EN 13704:2002	CHEMICAL DISINFECTANTS - QUANTITATIVE SUSPENSION TEST FOR THE EVALUATION OF SPORICIDAL ACTIVITY OF CHEMICAL DISINFECTANTS USED IN FOOD, INDUSTRIAL, DOMESTIC AND INSTITUTIONAL AREAS - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 1)
ISO 11138-1:2017	Sterilization of health care products — Biological indicators — Part 1: General requirements
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)
ISO 14971:2007	Medical devices Application of risk management to medical devices
EN 14347:2005	Chemical disinfectants and antiseptics - Basic sporicidal activity - Test method and requirements (phase 1)
EN 14561 : 2006	CHEMICAL DISINFECTANTS AND ANTISEPTICS - QUANTITATIVE CARRIER TEST FOR THE EVALUATION OF BACTERICIDAL ACTIVITY FOR INSTRUMENTS USED IN THE MEDICAL AREA - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 2)