Skip to content
Please enter a keyword to search

  • BS EN ISO 15883-1 : 2009

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006)

    Available format(s): 

    Superseded date:  29-08-2020

    Language(s): 

    Published date:  01-01-2009

    Publisher:  British Standards Institution

    Sorry this product is not available in your region.

    Add To Cart

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

    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
    8 Information to be supplied by the manufacturer
    9 Marking, labelling and packaging
    10 Information to be requested from the purchaser by the
       supplier of the WD
    Annex A (informative) - Test programme
    Annex B (informative) - A[O] concept - Comparative lethality
                            of moist heat processes
    Annex C (normative) - Test methods for the detection and
                          assessment of residual proteinaceous
                          contamination
    Annex D (normative) - Microbiological recovery medium for
                          estimation of bacterial contamination
                          of water
    Bibliography
    Annex ZA (informative) - Relationship between this European
                             Standard and the Essential Requirements
                             of EU Directive 93/42/EEC on medical
                             devices

    Abstract - (Show below) - (Hide below)

    Describes general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice.

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

    Committee LBI/35
    Development Note Supersedes BS 2745-1(1993) (05/2006) Supersedes 99/124125 DC. (06/2006) 2009 Editon Re-issued in September 2014 & incorporates AMD 1 2014. Supersedes 12/30252545 DC. (09/2014)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    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 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    IEC 60073:2002 Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators
    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 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 15883-3:2006 Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 1717:2000 Protection against pollution of potable water in water installations and general requirements of devices to prevent pollution by backflow
    ISO 12100:2010 Safety of machinery — General principles for design — Risk assessment and risk reduction
    ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    ISO 13849-2:2012 Safety of machinery — Safety-related parts of control systems — Part 2: Validation
    DIN 58955-3:1998-09 DECONTAMINATION-APPARATUS IN THE MEDICAL FIELD - EFFICIENCY TESTING
    IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
    ISO 9001:2015 Quality management systems — Requirements
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
    IEC 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    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.
    DIN 10510:2013-10 FOOD HYGIENE - COMMERCIAL DISHWASHING WITH MULTITANK-TRANSPORTDISHWASHERS - HYGIENE REQUIREMENTS, PROCEDURE TESTING
    IEC 60584-1:2013 Thermocouples - Part 1: EMF specifications and tolerances
    ISO 228-1:2000 Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    View more information

    • 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, flexibile and cost effective