16/30288024 DC : 0
NA
Status of Standard is Unknown
BS EN ISO 15883-4 - WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
Hardcopy , PDF
English
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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 |
| 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) |
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