SANS 452-2008 Non-reusable and reusable sharps containers《不可重复使用的及可重复使用的锐物容器》.pdf

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1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-21760-0 SANS 452:2008Edition 1SOUTH AFRICAN NATIONAL STANDARD Non-reusable and reusable sharps containers Published by Standards South Afr

4、ica 1 dr lategan road groenkloof private bag x191 pretoria 0001 tel: 012 428 7911 fax: 012 344 1568 international code + 27 12 www.stansa.co.za Standards South Africa SANS 452:2008 Edition 1 Table of changes Change No. Date Scope Acknowledgement Standards South Africa wishes to acknowledge the valua

5、ble assistance derived from publications of Standards Australia and Standards New Zealand. Foreword This South African standard was approved by National Committee StanSA SC 5140.37A, Medical devices Needles and syringes, in accordance with procedures of Standards South Africa, in compliance with ann

6、ex 3 of the WTO/TBT agreement. This document was published in June 2008. A reference is made in 4.2 to the packaging of sharps containers for road and rail transport in compliance with “the current relevant national legislation“. In South Africa this means the National Road Traffic Act, 1996 (Act No

7、. 93 of 1996) in terms of which SANS 10229-1 is mandatory. A reference is made in 4.4 to the disposal of sharps containers in a manner that is not contrary to “the current relevant national legislation“. In South Africa this means the Environment Conservation Act, 1989 (Act No. 73 of 1989). Annex A

8、forms an integral part of this standard. Annexes B and C are for information only. SANS 452:2008 Edition 1 1 Contents Page Acknowledgement Foreword 1 Scope 3 2 Normative references 3 3 Definitions 4 4 Requirements 5 4.1 Types 5 4.2 General. 5 4.3 Design and construction. 6 4.4 Materials. 6 4.5 Colou

9、r. 6 4.6 Fill capacity (FC) indicator 7 4.7 Opening 7 4.8 Closure device 7 4.9 Handles or any other integral carrying feature. 8 4.10 Drop test. 8 4.11 Simulated stacking using an applied load 8 4.12 Stacking stability. 8 4.13 Leakage and impact resistance 8 4.14 Durability of marking or labelling 9

10、 4.15 Penetration resistance 9 4.16 Decontamination process for reusable sharps containers. 9 5 Test methods . 10 5.1 Fill capacity of containers without an overfill prevention feature 10 5.2 Conditioning of sharps containers 10 5.3 Handle or any other integral carrying feature. 11 5.4 Drop test. 11

11、 5.5 Simulated stacking using an applied load 12 5.6 Stacking stability. 12 5.7 Leakage and impact resistance 12 5.8 Durability of marking or labelling 14 5.9 Penetration resistance 14 6 The use and handling of sharps containers 15 7 Marking and labelling 16 Annex A (normative) Method to validate th

12、e efficacy of the decontamination process for reusable sharps containers 17 Annex B (informative) Labels to be used on sharps containers in accordance with SANS 10229-1 20 Annex C (informative) Quality verification of non-reusable and reusable sharps containers. 21 Bibliography 21 SANS 452:2008 Edit

13、ion 1 2 This page is intentionally left blank SANS 452:2008 Edition 1 3 Non-reusable and reusable sharps containers 1 Scope This standard covers requirements for non-reusable and reusable containers used for the collection, transportation and processing of sharp objects (sharps) used in human and an

14、imal medical applications. It does not cover requirements for the brackets or other devices used to stabilize the containers, outer containers used for the collection and transportation of filled sharps containers, and the disposal of the contents of the sharps containers. 2 Normative references The

15、 following referenced documents are indispensable for the application 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. Information on currently valid national and internat

16、ional standards can be obtained from Standards South Africa. ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements. SANS 10229-1, Transport of dangerous goods Packaging and large packaging for road and rail transpor

17、t Part 1: Packaging. SANS 10232-3:2007, Transport of dangerous goods Emergency information systems Part 3: Emergency response guides. SANS 10248-1, Management of healthcare waste Part 1: Management of healthcare risk waste from a healthcare facility. VC 8054, Disinfectants and detergent-disinfectant

18、s. SANS 452:2008 Edition 1 4 3 Definitions For the purposes of this standard, the following definitions apply. 3.1 accredited laboratory laboratory certified by an accreditation authority, such as SANAS (South African Accreditation Systems) as competent to perform specific tests 3.2 cytotoxic waste

19、waste that is toxic to cells and that can lead to cell death SANS 10248-1:2008 3.3 decontamination physical or chemical means to remove, inactivate, or destroy pathogens on a surface or item to the point where they are no longer capable of transmitting infectious diseases and the surface or item is

20、rendered safe for handling, for use or for disposal 3.4 disinfection reduction of the number of viable micro-organisms on a product to a level previously specified as appropriate for its intended further handling or use ISO 15883-1:2006 3.5 fill capacity FC volume intended by the manufacturer beyond

21、 which it is considered unsafe to deposit sharps into a sharps container 3.6 fill capacity indicator embossed mark or line on the outer wall of the container corresponding to the FC 3.7 genotoxic substance that is capable of interacting directly with genetic material, causing DNA damage that can be

22、assayed for analysis and DNA damage that can be passed on to off-spring SANS 10248-1:2008 3.8 gross mass maximum mass of the container and the contents as intended by the manufacturer 3.9 leakage resistance ability of a container to prevent the escape of liquid 3.10 lifespan total number of times th

23、at a reusable container is designed to be reused as stated by the SANS 452:2008 Edition 1 5 manufacturer when reprocessed in accordance with the method prescribed by the manufacturer 3.11 non-reusable sharps container container designated to be filled to its fill capacity once only and then to be de

24、stroyed with its contents 3.12 penetration movement of a needle through a medium until the point of the needle first exits the medium on the side opposite the point of entry 3.13 penetration force force applied to a hypodermic needle with a nominal diameter of 0,8 mm and at a penetration rate of 100

25、 mm/min to achieve penetration 3.14 reusable sharps container container designated as suitable for reprocessing and reuse for the lifespan of the container 3.15 sharps objects or devices with sharp points, protuberances or cutting edges such as needles, syringes, blades, clinical glass or other item

26、s, that are capable of cutting or piercing the skin or mucous membranes or puncturing the container in which they are held 3.16 sharps container receptacle intended for the collection and disposal of used and contaminated sharps 3.17 stacking height vertical distance from the outer base of the conta

27、iner to the upper surface onto which another container of the same type and size will rest when stacked 3.18 total nominal capacity TC maximum volume of the container, in litres, as indicated by the manufacturer 4 Requirements 4.1 Types A sharps container shall be one of the following types: a) non-

28、reusable; or b) reusable. 4.2 General Sharps containers shall comply with the current relevant national legislation (see foreword) for packaging for road and rail transport. The design of each sharps container shall be tested by an accredited laboratory for compliance with SANS 10229-1, and in corre

29、spondence with the SANS 452:2008 Edition 1 6 requirements in 4.10, 4.11 and 4.12 of this standard. Upon successful completion of the tests, a certificate of compliance shall be issued to the consignor and the marking denoting compliance in accordance with SANS 10229-1, affixed to the container (see

30、7.4). 4.3 Design and construction 4.3.1 Sharps containers shall be designed and constructed to present the minimum risk to the person(s) handling the sharps containers during the use, collection, transportation and disposal of the sharps. 4.3.2 Sharps containers that need to be assembled before use

31、shall be such that they can be assembled manually without using excessive force. 4.3.3 The lid of a non-reusable container shall be so designed that, once secured, it cannot be removed manually without major structural damage (breakage) to the container. 4.3.4 The lid of a reusable container shall b

32、e so designed that it can only be opened mechanically following final closure. 4.3.5 Sharps containers that include an aperture for removing needles shall be so designed that the location of the aperture allows for safe, one-handed removal of the needle. NOTE Needles should not be removed from devic

33、es wherever possible. 4.3.6 Sharps containers shall be so designed that a) they can remain upright during use or be provided with customized brackets or other means to achieve the same result, and b) the level of the contents can be readily determined before final closure. NOTE 1 The level of the co

34、ntents can be obvious when the device that prevents further insertion of sharps into the filled container is activated or the level of sharps is visible through the container opening, the closure device or a transparent part of the container. NOTE 2 Sharps containers should a) have a mechanism where

35、by overfilling can be prevented, and b) be so designed that syringes with attached needles lie horizontally when placed inside the sharps container. 4.4 Materials Sharps containers shall be made of material that, if ultimately disposed of, will not produce emissions or residues or persist in an envi

36、ronment in a manner contrary to the current relevant national legislation (see foreword). NOTE Heavy metals and halogenated materials should not be used in the manufacture of sharps containers. 4.5 Colour 4.5.1 The colour of the sharps containers shall be predominantly yellow in accordance with SANS

37、 10248-1. 4.5.2 A sharps container intended for the collection of sharps contaminated with cytotoxic substances shall have dark green identification marking in accordance with SANS 10248-1. SANS 452:2008 Edition 1 7 NOTE The identification marking can be in the form of a dark green label, dark green

38、 printing, a dark green component of the container such as a lid, or other means. 4.6 Fill capacity (FC) indicator 4.6.1 General 4.6.1.1 There shall be an FC indicator on the outer wall of the sharps container. 4.6.1.2 The FC indicator shall be such that when filled to the FC, the contents of the sh

39、arps container shall not interfere with the functionality of the closure device or an overfill prevention feature, as relevant. 4.6.2 Position of the FC indicator 4.6.2.1 Sharps containers with an overfill prevention feature The level of the FC indicator shall be determined by the design of the cont

40、ainer and shall be at the level a) where the automatic overfill prevention feature is activated, such as a counter lever tray, or b) of the base of a drop-down feature (curved liner) beyond which no additional filling is intended to take place. 4.6.2.2 Sharps containers without an overfill preventio

41、n feature When tested in accordance with 5.1, the FC indicator shall be at a level no higher than 75 % of the total nominal capacity (TC) of the container. 4.7 Opening The opening of a sharps container shall: a) be appropriate for the intended use of the container; b) promote one-handed disposal of

42、sharps without compromising safety; c) minimize catching or snagging of sharps during insertion; d) restrict hand entry; and e) restrict the removal of contents from the container. 4.8 Closure device The closure device of a sharps container shall: a) be securely attached and integral with the contai

43、ner when in use; b) be capable of being securely closed when the container is filled to the FC; c) be activated without the risk of sharps injury to the operator; d) completely cover an aperture intended for removing needles when closed; and SANS 452:2008 Edition 1 8 e) be resistant to manual openin

44、g once the final closure mechanism is activated. 4.9 Handles or any other integral carrying feature 4.9.1 Sharps containers shall be provided with a means for carrying such as a handle that connects opposite sides of the container or any other integral carrying feature, for example, finger recesses,

45、 protrusions or flanges. 4.9.2 Integral carrying features, such as finger recesses, protrusions or flanges, shall be placed above the FC level. 4.9.3 The handles shall be manufactured from material compatible with the disposal process intended by the manufacturer of the sharps container. 4.9.4 The h

46、andles or any other integral carrying feature shall not: a) interfere with the placement of sharps into the container; and b) not be part of the closure device. 4.9.5 When tested in accordance with 5.3, a) the handle or any other integral carrying feature shall remain intact and not be separated fro

47、m the container; and b) there shall be no evidence of cracks, ruptures, tears, or spillage of the contents at the site of attachment of the handle or any other integral carrying feature. 4.10 Drop test When containers are tested in accordance with 5.4, a) the container shall not rupture nor split at

48、 its joining seams; b) the lid or closure device shall remain securely closed; and c) there shall be no disconnection of any of the components of the container. 4.11 Simulated stacking using an applied load When tested in accordance with 5.5, the sharps containers shall not leak nor show signs of de

49、terioration, distortion, cracking or leakage. 4.12 Stacking stability When tested in accordance with 5.6, two sharps containers stacked on top of the test specimen shall maintain their position for at least 1 h. 4.13 Leakage and impact resistance 4.13.1 Leakage resistance When tested in accordance with 5.7.3.1, the container shall not show any signs of deterioration or deformation, and there shall be no evidence of wetting of the outer surface of the container. SANS 452:2008 Edition 1 9 4.13.2 Impact resistance When tested in accordance with 5.7.3.2, a) the co