CSA Z316.6:20

(ISO 23907-2:2019, MOD)

National Standard of Canada

CSA Z316.6:20

Sharps injury protection — Requirements and test methods — Sharps containers

(ISO 23907-2:2019, MOD)

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  CSA Z316.6:20

  December 2020

  
  

  Title: Sharps injury protection — Requirements and test methods — Sharps containers

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National Standard of Canada

CSA Z316.6:20

Sharps injury protection — Requirements and test methods — Sharps containers (ISO 23907-2:2019, MOD)

Prepared by

International Organization for Standardization

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ICS 11.040.99

ISBN 978-1-4883-3150-3

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CSA Z316.6:20

Sharps injury protection — Requirements and test methods —

Sharps containers

CSA Z316.6:20

Sharps injury protection — Requirements and test methods — Sharps containers (ISO 23907-2:2019, MOD)

CSA Preface

This is the fifth edition of CSA Z316.6, Sharps injury protection — Requirements and test methods — Sharps containers, which is an adoption, with Canadian deviations, of ISO (International Organization for Standardization) Standard 23907-2 (first edition, 2019-11), titled Sharps injury protection — Requirements and test methods — Part 2: Reusable sharps containers. It supersedes the previous edition, published in 2014 as CAN/CSA-Z316.6 (adopted ISO 23907:2012).

For brevity, this Standard will be referred to as “CSA Z316.6” throughout.

This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard.

This Standard was reviewed for Canadian adoption by the CSA Subcommittee on Sharps Containers, under the jurisdiction of the CSA Technical Committee on Medical Laboratory Quality Systems and the CSA Strategic Steering Committee on Health and Well-being, and has been formally approved by the Technical Committee.

This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.

© 2020 Canadian Standards Association

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December 2020 © 2020 Canadian Standards Association CSA/5

CSA Z316.6:20

Sharps injury protection — Requirements and test methods —

Sharps containers

the following information to inquiries@csagroup.org and include “Proposal for change” in the subject line:

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December 2020 © 2020 Canadian Standards Association CSA/6

ISO 23907-2:2019(E)

Contents Page

Foreword iv

Introduction v

1. Scope 1

2. Normative references 1

3 Terms and definitions 1

4 Requirements and recommendations 4

4.1 General 4

1. Design and construction 4

   1. General 4

   2. Container stability 4

1. Strength of handles 4

2. Aperture and closure 4

3. Resistance to penetration 5

4. Resistance to damage or leakage after dropping 5

5. Resistance to damage or leakage after toppling 5

6. Fill line 5

1. Closure device 6

2. Monitoring of reuses 6

3. Cleaning and decontamination 6

   1. Cleaning and decontamination process 6

   2. Microbiological validation 7

5 Lifespan simulation prior to testing 7

5.1 General 7

1. Conditioning 7

2. Tumbling with sharps simulation 7

3. Transport simulations 8

4. Processing simulations 8

6 Test methods 8

6.1 Container stability 8

1. Strength of handle(s) 8

2. Resistance to penetration 9

   1. Apparatus 9

   2. Procedure 9

3. Resistance to damage and leakage after dropping 10

   1. Apparatus 10

   2. Procedure 10

1. Resistance to spillage by toppling 11

   1. Apparatus 11

   2. Procedure 11

1. Quality monitoring: Post decontamination quality assurance 11

2. Labelling and marking and instructions for use 12

   1. Labelling and marking 12

   2. Instructions for use 13

Annex A (informative) Microbiological validation 14

Bibliography 17

© ISO 2019 – All rights reserved

CSA Z316.6:20

iii

ISO 23907-2:2019(E)

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

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This document was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and catheters.

A list of all parts in the ISO 23907 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www.iso.org/members.html.

iv CSA Z316.6:20

© ISO 2019 – All rights reserved

ISO 23907-2:2019(E)

Introduction

Reusable sharps containers are designed for the containment and disposal of sharps such as scalpel blades, trocars, hypodermic needles and syringes. They are supplied in a wide range of sizes and can be manufactured from a variety of materials. This document does not specify the size range of the containers or the materials selected to manufacture the containers.

Sharps containers can be either single-use or reusable. This document covers reusable sharps containers.

© ISO 2019 – All rights reserved

CSA Z316.6:20 v

INTERNATIONAL STANDARD ISO 23907-2:2019(E)

Sharps injury protection — Requirements and test methods —

Part 2:

Reusable sharps containers

1. Scope

   This document specifies requirements for reusable sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars, hypodermic needles and syringes.

   This document is applicable to sharps containers that are supplied complete by the manufacturer and to those that are supplied as components intended to be assembled by the user.

   It is not applicable to single use sharps containers (refer to ISO 23907-1 for such containers).

   This document includes design functionality for user safety, lifespan simulation, cleaning and decontamination, microbiological validation, quality monitoring and performance testing.

   
   

2. Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 7864, Sterile hypodermic needles for single use — Requirements and test methods

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

• ISO Online browsing platform: available at https://www.iso.org/obp

• IEC Electropedia: available at https://www.electropedia.org/

3.1

aperture

opening of the sharps container through which sharps (3.21) are deposited for disposal

3.2

clean

visually free of soil, debris and organic matter

3.3

closure feature

flap, plug, lid or slide that is intended to close the aperture (3.1)

© ISO 2019 – All rights reserved

CSA Z316.6:20 1