《BS-6196-1989.pdf》由会员分享,可在线阅读,更多相关《BS-6196-1989.pdf(18页珍藏版)》请在三一文库上搜索。
1、BRITISH STANDARD BS 6196:1989 Incorporating Amendment No. 1 Specification for Sterile epidural catheters and introducer needles for single use UDC 616 072.2:616 089.84 7:001.4:006.3/.8:620.1 Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:45 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS
2、 6196:1989 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Board of BSI and comes into effect on 31 July 1989 BSI 11-1999 First published February 1982 First revision July 1989 The following BSI r
3、eferences relate to the work on this standard: Committee reference HCC/27 Draft for comment 87/55315 DC ISBN 0 580 17148 5 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Commit
4、tee HCC/27, upon which the following bodies were represented: Association for Medical Physics Technology Association of Anaesthetists of Great Britain and Ireland Association of Clinical Pathologists British Dietetic Association (PENG) British Health-Care Trade and Industry Council British Institute
5、 of Radiology British Paediatric Association British Plastics Federation British Rubber Manufacturers Association British Surgical Trades Association Incorporated College of Radiographers Department of Health and Social Security Disposable Hypodermic and Allied Equipment Manufacturers Association (U
6、K) Intensive Care Society Malaysian Rubber Producers Research Association Medical Sterile Products Association National Association of Theatre Nurses Pharmaceutical Society of Great Britain Royal College of Radiologists Royal College of Surgeons of England Coopted members Amendments issued since pub
7、lication Amd. No.Date of issueComments 6458November 1990 Indicated by a sideline in the margin Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:45 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6196:1989 BSI 11-1999i Contents Page Committees responsibleInside front cover Forewordii Sectio
8、n 1. General 1Scope1 2Definitions1 3Finish1 4Freedom from biological hazard1 5Packaging1 6Marking2 Section 2. Sterile epidural catheters and catheter stylets 7Catheter3 8Catheter stylet3 Section 3. Sterile epidural introducer needles and needle stylets 9Epidural introducer needle5 10Epidural introdu
9、cer needle stylet5 Appendix A Guidance for design and materials7 Appendix B Symbol for single use7 Appendix C Method of test for determining the strength of union between catheter and non-detachable hub7 Appendix D Methods of test for determining the security of union between catheter and detachable
10、 hub and between catheter stylet and button8 Appendix E Method of test for corrosion resistance8 Appendix F Methods of test for determining the security of union between epidural introducer needle and hub and between epidural introducer needle stylet and button9 Appendix G Method of test for dullnes
11、s of point of epidural introducer needle9 Figure 1 Epidural catheter4 Figure 2 Epidural introducer needle and stylet6 Figure 3 ISO symbol “Do not re-use”, registration number ISO 7000/10517 Publications referred toInside back cover Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:45 GMT+
12、00:00 2006, Uncontrolled Copy, (c) BSI BS 6196:1989 ii BSI 11-1999 Foreword This first revision of BS 6196 was prepared under the direction of the Health Care Standards Policy Committee. BS 6196 was first published in 1982 and was prepared at the request of the Department of Health and Social Securi
13、ty. The main differences from the 1982 edition, which is now withdrawn, are as follows. a) Requirements for freedom from biological hazard are introduced. b) The minimum length of the epidural catheter is not specified, so as to allow shorter catheters for specialized applications such as paediatric
14、 use. However, it is still recognized that epidural catheters for adult use should be at least 900 mm in length. c) Additional distance marks on the epidural catheter are introduced at the request of clinicians, who find them useful in fine adjustment of the extent of catheter insertion. A separate
15、system of distance marking is introduced for catheters for paediatric use. d) A fixed length for the epidural introducer needle is not specified, so as to permit, at the request of clinicians, a range of lengths (in multiples of 10 mm) for particular applications such as paediatric use or use in obe
16、se patients. The committee responsible for this standard has not found it practicable to specify criteria for rigidity or resistance to kinking, coiling or knotting, nor to specify particular materials with these characteristics. However, design guidance is given in Appendix A. It has not yet been f
17、ound possible to specify a satisfactory method of measuring radio-opacity. However, the packaging of epidural catheters that are made of material which is inherently radio-opaque, or to which a radio-opacifying agent has been admixed, is to be marked “RADIO-OPAQUE”. Single-use epidural equipment sho
18、uld be manufactured and sterilized in accordance with the recommendations in the “Guide to Good Manufacturing Practice for Sterile Medical Devices and Surgical Products”1). Attention is also drawn to the Manufacturers Registration Scheme administered by the Department of Health and Social Security.
19、Single-use epidural equipment should never be reused, nor subjected to any further sterilization process before use. WARNING NOTE. Attention is particularly drawn to the danger of pulling back the catheter through the epidural introducer needle (see clause 6) because on occasions a piece of the cath
20、eter has been severed and left in the epidural space. Due cognizance should be taken of this possibility when assessing compatibility of materials of construction with human tissue. Product certification. Users of this British Standard are advised to consider the desirability of third party certific
21、ation of product conformity with this British Standard based on testing and continuing surveillance, which may be coupled with assessment of a suppliers quality systems against the appropriate Part of BS 5750. Enquiries as to the availability of third party certification schemes will be forwarded by
22、 BSI to the Association of Certification Bodies. If a third party certification scheme does not already exist, users should consider approaching an appropriate body from the list of Association members. 1) Published by the Department of Health and Social Security and available from HMSO, 49 High Hol
23、born, London, WC1. (ISBN 0 11 320770 0). Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:45 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6196:1989 BSI 11-1999iii A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are re
24、sponsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i to iv, pages 1 to 10, an inside back cover and a back cover. This standard has
25、 been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:45 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffie
26、ldun, na, Tue Dec 05 01:26:45 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6196:1989 BSI 11-19991 Section 1. General 1 Scope This British Standard specifies basic requirements, including requirements for packaging, for epidural catheters and epidural introducer needles which are supplied sterile fo
27、r single use. NOTE 1Equipment may be supplied separately or together in an epidural set. NOTE 2The titles of the publications referred to in this standard are given on the inside back cover. NOTE 3Appendix A gives guidance on design and materials, and Appendix G suggests a method of test for the dul
28、lness of the epidural introducer needle point. 2 Definitions For the purpose of this British Standard, the following definitions apply. 2.1 epidural catheter flexible tube designed to introduce liquids into the epidural space 2.2 epidural catheter stylet device to assist the insertion of the cathete
29、r 2.3 patient end that end of the catheter which is introduced into the epidural space 2.4 free end that end of the catheter which remains external to the patient 2.5 eye opening between the inside and the outside of the catheter 2.6 hub component at the free end of the catheter or epidural introduc
30、er needle incorporating a conical female taper 2.7 epidural introducer needle rigid metal tube of suitable length to enable the introduction of an epidural catheter into the epidural space. It includes a hub and a formed end which may, by nature of its configuration, assist the deflection of the cat
31、heter. An epidural introducer needle stylet is always provided 2.8 epidural introducer needle stylet device to occlude the epidural introducer needle during insertion 2.9 epidural set an epidural catheter and one or more ancillary devices packaged in the same unit container NOTEComponents of a typic
32、al epidural set for single use are illustrated in Figure 1 and Figure 2, which include terms used to describe component parts. 3 Finish When examined by normal or corrected vision without magnification, all components shall appear smooth and free from flash, surface irregularities, moulding and extr
33、usion defects. When examined under 2.5 magnification the components shall appear free from extraneous matter. 4 Freedom from biological hazard When tested in their final form, after sterilization, in accordance with the principles and methods recommended in BS 5736, epidural catheters and epidural i
34、ntroducer needles shall be assessed as being free from biological hazard. 5 Packaging 5.1 General Each epidural catheter, epidural introducer needle, or epidural set shall be sealed in a unit container. One or more unit containers shall be packed into an outer container. 5.2 Unit containers The unit
35、 container shall permit sterilization of the contents in situ. It shall ensure maintenance of sterility and provide protection of the contents during handling, transit and storage. The unit container shall be so designed as to permit the product to be presented for use in an aseptic manner. NOTEOnce
36、 the unit container has been opened it should not be possible to reseal it easily and it should clearly reveal that it has been opened. Unit containers should be stored in their outer containers in cool, dry, dark, reasonably dust-free conditions and not exposed to ionizing radiation. Licensed Copy:
37、 sheffieldun sheffieldun, na, Tue Dec 05 01:26:45 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6196:1989 2 BSI 11-1999 6 Marking 6.1 Unit containers Unit containers for epidural catheters, epidural introducer needles or epidural sets shall be marked with, or shall display on an insert, the followin
38、g information. a) Description of contents including: 1) the designated size in accordance with 7.1 or 9.1, as appropriate; 2) whether for paediatric use; 3) the distance indicator marking system; 4) for an epidural introducer needle packed separately, the size of the catheter for which it is intende
39、d. b) The word “STERILE”. c) The words “FOR SINGLE USE” or equivalent. NOTEThe symbol described in Appendix B may also be shown. d) A warning against use of the device if the package is open or damaged. e) A prominent warning notice in the labelling on packs of epidural catheters and on epidural set
40、s, reading as follows: “CAUTION: Never pull back the catheter through the epidural introducer needle.” f) The word “RADIO-OPAQUE”, if appropriate. NOTEThe word “RADIO-OPAQUE” only implies the addition of a radio-opacifying medium to the epidural catheter material or the use of an inherently radio-op
41、aque material, both with the intention of rendering the epidural catheter opaque to X-rays. g) The batch number and date of manufacture, or a batch number from which the date of manufacture (month and year) may be determined. h) The name and/or registered trade mark of the manufacturer or supplier.
42、i) The number of this British Standard, i.e. BS 61962). 6.2 Outer container or containers The outer container or containers shall be marked with the following information. a) Description of contents see 6.1 a). b) The word “STERILE”. c) The words “FOR SINGLE USE” or equivalent. NOTEThe symbol descri
43、bed in Appendix B may also be shown. d) The word “RADIO-OPAQUE”, if appropriate see Note to 6.1 f). e) The name and address of the manufacturer and/or supplier. f) The date of sterilization (month and year). g) The batch number and date of manufacture see 6.1 g). h) The number of this British Standa
44、rd, i.e. BS 61962). 2) Marking BS 6196 on or in relation to a product represents a manufacturers declaration of conformity, i.e. a claim by or on behalf of the manufacturer that the product meets the requirements of the standard. The accuracy of the claim is therefore solely the responsibility of th
45、e person making the claim. Such a declaration is not to be confused with third party certification of conformity, which may also be desirable. Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:45 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6196:1989 BSI 11-19993 Section 2. Sterile epidu
46、ral catheters and catheter stylets 7 Catheter 7.1 Size designation The size of epidural catheters shall be designated by the following. a) Outside diameter of the catheter expressed in millimetres to the nearest 0.1 mm. b) Effective length of the catheter, excluding hub assembly, expressed in millim
47、etres (see Figure 1). NOTEThis standard does not specify the length. Epidural catheters intended for use in adults should have a minimum length of 900 mm. 7.2 Mechanical properties 7.2.1 Epidural catheters with non-detachable hubs. When tested in accordance with Appendix C, the strength of the union
48、 between the catheter and the hub shall exceed the yield point of the catheter or 15 N whichever is less. In neither case shall the union be loosened or show signs of damage. 7.2.2 Epidural catheters with detachable hubs. When tested in accordance with Appendix D, the hub shall not become detached f
49、rom the catheter. 7.3 Hub 7.3.1 The free end of the catheter shall be provided with a hub having a female 6 % (Luer) taper conical fitting in accordance with either BS 3930-1 or BS 3930-2. 7.3.2 The hub assembly shall be provided with a closure. 7.4 Eyes 7.4.1 If lateral eyes are provided they shall not extend more than 20 mm from the tip of the patient end of the catheter. 7.4.2 When examined by normal or corrected vision without magnification, the edges of the eyes shall appear smooth. 7.5 Patient end If the patient end is closed, it shall be rounded.
链接地址:https://www.31doc.com/p-3772190.html