CSA Z15883-5:09 (R2019)

Foreword
Introduction
1 Scope
2 Normative references
3 Applicability
Annex A (normative) - Test soil and method for surgical
        instruments (Austria)
Annex B (normative) - Test soil and method for anaesthesia
        equipment (Austria)
Annex C (normative) - Test soil and method for bedpans
        (Austria)
Annex D (normative) - Test soil and method for urine bottles
        (Austria)
Annex E (normative) - Test soil and method for flexible
        endoscopes (Austria)
Annex F (normative) - Test soil and method for flexible
        endoscopes (France)
Annex G (normative) - Test soil and method for surgical
        instruments, glassware and anaesthesia equipment
        (Germany)
Annex H (normative) - Test soil and method for bedpans
        (Germany)
Annex I (normative) - Test soil and method for flexible
        endoscopes (Germany)
Annex J (normative) - Test soil and method for surgical
        instruments and flexible endoscopes, Peroxidase
        test (Germany)
Annex K (normative) - Test soil and method for stainless
        steel items including surgical instruments
        (Netherlands)
Annex L (normative) - Test soil and method for surrogate
        devices for endoscope channels (Netherlands)
Annex M (normative) - Test soils and methods for surgical
        instruments, wash bowls, bedpans, urine bottles,
        anaesthesia equipment, baby bottles and suction
        bottles (Sweden)
Annex N (normative) - Test soil and method for surgical
        instruments, surgical instrument trays bowls,
        dishes and receivers (UK)
Annex O (normative) - Test soil and method for anaesthetic
        accessories (UK)
Annex P (normative) - Test soil and method for bedpans and
        commode pans (UK)
Annex Q (normative) - Test soil and method for urine bottles
        (UK)
Annex R (normative) - Test soil and method for flexible
        endoscopes (UK)
Annex S (informative) - Test soil and method for reusable
        medical instruments (USA)
Bibliography

CSA Preface This is the first edition of CAN/CSA-Z15883-5, Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning efficacy, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Technical Specification 15883-5 (first edition, 2005-11-15). This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada. Scope This Technical Specification includes the test soils and methods that can be used to demonstrate the cleaning efficacy of washer-disinfectors (WD) according to the ISO 15883 series of standards. The inclusion of the test soils and methods in this Technical Specification does not indicate that they are of equivalent sensitivity in their determination of cleaning efficacy. Acceptance criteria are included, based on visual inspection and/or a microbiological end-point as stated for each method. Where chemical detection of residual soiling is required/sought, methods can be complemented by the specific determination of a residual component of the applied test soil. NOTE 1 The test soils and methods included in this Technical Specification are sourced from national standards and published documents submitted by member bodies of the Technical Committee preparing this Technical Specification. They have been edited only to provide a uniform format within this Technical Specification. NOTE 2 An example of this is the use of the peroxidase test (see Annex J) to detect residual blood (haemoglobin) from the test soil applied to surgical instruments or flexible endoscopes (e.g. using the method described in Annex G). See also ISO 15883-1:2005, Annex D.

CSA Preface This is the first edition of CAN/CSA-Z15883-5, Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning efficacy, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Technical Specification 15883-5 (first edition, 2005-11-15). This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada. Scope This Technical Specification includes the test soils and methods that can be used to demonstrate the cleaning efficacy of washer-disinfectors (WD) according to the ISO 15883 series of standards. The inclusion of the test soils and methods in this Technical Specification does not indicate that they are of equivalent sensitivity in their determination of cleaning efficacy. Acceptance criteria are included, based on visual inspection and/or a microbiological end-point as stated for each method. Where chemical detection of residual soiling is required/sought, methods can be complemented by the specific determination of a residual component of the applied test soil. NOTE 1 The test soils and methods included in this Technical Specification are sourced from national standards and published documents submitted by member bodies of the Technical Committee preparing this Technical Specification. They have been edited only to provide a uniform format within this Technical Specification. NOTE 2 An example of this is the use of the peroxidase test (see Annex J) to detect residual blood (haemoglobin) from the test soil applied to surgical instruments or flexible endoscopes (e.g. using the method described in Annex G). See also ISO 15883-1:2005, Annex D.