DRAFT UGANDA STANDARD

Transcription

1 DRAFT UGANDA STANDARD DUS 2011 First Edition 2018-mm-dd Sterile surgical blades Specification Reference number DUS 2011: 2018 UNBS 2018

2 DUS 2011: 2018 Compliance with this standard does not, of itself confer immunity from legal obligations A Uganda Standard does not purport to include all necessary provisions of a contract. Users are responsible for its correct application UNBS2018 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilised in any form or by any means, electronic or mechanical, including photocopying and microfilm, without prior written permission from UNBS. Requests for permission to reproduce this document should be addressed to The Executive Director Uganda National Bureau of Standards P.O. Box 6329 Kampala Uganda Tel: /1/2/3 Fax: info@unbs.go.ug Web: ii UNBS 2018 All rights reserved

3 DUS 2011:2018 Foreword Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry of Trade, Industry and Cooperatives established under Cap 327, of the Laws of Uganda, as amended. UNBS is mandated to coordinate the elaboration of standards and is (a) a member of International Organisation for Standardisation (ISO) and (b) a contact point for the WHO/FAO Codex Alimentarius Commission on Food Standards, and (c) the National Enquiry Point on TBT Agreement of the World Trade Organisation (WTO). The work of preparing Uganda Standards is carried out through Technical Committees. A Technical Committee is established to deliberate on standards in a given field or area and consists of key stakeholders including government, academia, consumer groups, private sector and other interested parties. Draft Uganda Standards adopted by the Technical Committee are widely circulated to stakeholders and the general public for comments. The committee reviews the comments before recommending the draft standards for approval and declaration as Uganda Standards by the National Standards Council. The committee responsible for this document is Technical Committee UNBS/TC 14, Medical devices. UNBS 2018 All rights reserved iii

4

5 DRAFT UGANDA STANDARD DUS 2011: 2018 Sterile surgical blades Specification 1 Scope This Draft Uganda standard specifies the requirements, methods of test and sampling of sterile surgical blades. 2 Normative references The following referenced documents 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. ASTM A a, Standard Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products DUS ISO 7740, Instruments for surgery -- Scalpels with detachable blades -- Fitting dimensions DUS ISO 13402, Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure ISO , Sampling procedures for inspection by attributes -- Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection US ISO , Metallic materials Rockwell hardness test Part 1: Test method 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 burr Piece of metal projection not normally inherent to smooth uniform surface. 3.2 feather thin, turned,projecting or curled edge not removed by honing or buffing 3.3 incision surgical cut made in skin or flesh 3.4 jag several small tooth-like projections or similar indentations, individually smaller than nicks. UNBS 2018 All rights reserved 1

6 DUS 2011: nick chipped-out, broken-out, indented or bent-out piece of metal or any similar gap or indentation 3.6 surgical blade blades used for cutting skin and tissue during surgical procedures 3.7 waviness undulation of cutting edge. 4 Requirements 4.1 General requirements The blade shall be highly polished and free from any blemishes. All edges, other than the cutting edge, shall be rounded. The edges other than the cutting shall not be sharp The blade shall be made of surgical grade 316 stainless steel The tip of the blade shall be well defined and sharp There shall be no waviness, jags, feathers, burrs, nicks or other defects on the cutting edge when examined in under a magnification of 10X The surgical blade shall have a slot and both surfaces of the blade and all sides of the slot shall be uniform, free from roughness, waviness and shall not show any sign of corrosion or rust. 4.2 Quality requirements Chemical composition The surgical blade shall conform to one of the following composition given in table 1 when tested in accordance with the test method given therein. Table 1 Chemical composition for stainless grade 316 steel surgical blade Element Percentage Test methods Carbon, max 0.08 Manganese, max 2.0 Phosphorus,max Sulphur, max 0.03 ASTM A a Silicon, max 0.75 Chromium Nickel Nitrogen Molybdenum UNBS 2018 All rights reserved

7 DUS 2011: Surgical blade number The surgical blade shall be classified according to surgical blade numbers. The thickness of the fitting area of the blade shall be between 0.37mm and 0.42mm Hardness When tested in accordance with US ISO , the hardness of the surgical blade shall not exceed 95 Rockwell HB Corrosion resistant The blade shall not show any red stains or spots when examined with copper sulphate test given in DUS ISO Blade handle fitment. The blade handle fitment shall conform to DUS ISO 7740 specifications. 4.3 performance test When examined in accordance with annex A, the surgical blade shall cut easily and cleanly along the entire length of the cutting edge. On completion of the test, the blade shall show no sign of damage when examined under magnification 10X. 5 Sterility The surgical blade shall be sterile when tested in accordance with annex B. 6 Packaging 6.1 The blades shall be individually packaged in aluminium foil peel back with VC paper which shall maintain the blade in its sterile state until when opened. 6.2 The primary packaged shall be tested for 6.3 A number of individually packed surgical blade may be packaged in a box. 7 Labelling 7.1 Surgical blade The surgical blade shall be legibly and indelibly marked with the following: a) Blade number b) the word stainless steel or (SS); and c) manufacturer s code 7.2 Primary package The primary package shall be legibly and indelibly marked with the following information UNBS 2018 All rights reserved 3

8 DUS 2011:2018 1) Manufacturer s name and /or trade mark; 2) name of product, surgical blade ; 3) country of origin; 4) material used stainless steel or (SS), 5) sterile; 6) sterilisation method; 7) blade number; 8) batch number; 9) cautions like don t use if found open and single use only ; and 10) date of manufacture and expiry. 7.3 secondary package The secondary package shall be legibly and indelibly marked with the following information: i) Name and address of the manufacturer/ packer/distributor; ii) name of product; iii) surgical blade number, iv) sterile; v) sterilisation method; vi) country of origin; vii) number of surgical blades packed; viii) batch number; ix) date of Manufacture and expiry; and x) pictorial of the surgical blade, 8 Sampling Sampling shall be done in accordance with ISO UNBS 2018 All rights reserved

9 DUS 2011: 2018 Annex A (normative) performance test. A.1 procedure A.1 Cut a piece of curried leather 5 mm thick with moderate pressure using a surgical blade five times 100 mm long. A.2 Examine the surgical blade under the magnification of 10X. UNBS 2018 All rights reserved 5

10 DUS 2011:2018 Annex B (normative) Sterility B.1 Introduction The following culture media have been found to be suitable for the test for sterility. Fluid thioglycollate medium is primarily intended for the culture of anaerobic bacteria; however, it will also detect aerobic bacteria. Soyabean casein digest medium is suitable for the culture of both fungi and aerobic bacteria. B.2 Fluid thioglycollate medium L-Cystine Agar Sodium chloride Glucose monohydrate/anhydrous Yeast extract (water-soluble) Pancreatic digest of casein Sodium thioglycollate or Thioglycollic acid Resazurin sodium solution (1g/L of resazurin sodium), freshly prepared Water R 0.5 g 0.75 g 2.5 g 5.5 g/5.0 g 5.0 g 15.0 g 0.5 g 0.3 ml 1.0 ml 1000 ml ph after sterilisation 7.1 ± 0.2 B.2.1 Mix the L-cystine, agar, sodium chloride, glucose, water-soluble yeast extract and pancreatic digest of casein with the water R and heat until solution is effected. B.2.2 Dissolve the sodium thioglycollate or thioglycollic acid in the solution and, if necessary, add 1 M sodium hydroxide so that, after sterilisation, the solution will have a ph of 7.1 ± 0.2. If filtration is necessary, heat the solution again without boiling and filter while hot through moistened filter paper. B2.3 Add the resazurin sodium solution, mix and place the medium in suitable vessels which provide a ratio of surface to depth of medium such that not more than the upper half of the medium has undergone a colour change indicative of oxygen uptake at the end of the incubation period. Sterilise using a validated process. If the medium is stored, store at a temperature between 2 C and 25 C in a sterile, airtight container. B.2.4 If more than the upper one-third of the medium has acquired a pink colour, the medium may be restored once by heating the containers in a water-bath or in free- flowing steam until the pink colour disappears and cooling quickly, taking care to prevent the introduction of non-sterile air into the container. Do not use the medium for a longer storage period than has been validated.fluid thioglycollate medium is to be incubated at C. 6 UNBS 2018 All rights reserved

11 DUS 2011: 2018 B.2.5 For products containing a mercurial preservative that cannot be tested by the membrane-filtration method, fluid thioglycollate medium incubated at C may be used instead of soya-bean casein digest medium provided that it has been validated as described in growth promotion test. B.3 Alternative thioglycollate medium Where prescribed or justified and authorised, the following alternative thioglycollate medium may be used. Prepare a mixture having the same composition as that of the fluid thioglycollate medium, but omitting the agar and the resazurin sodium solution, sterilise as directed above. The ph after sterilisation is 7.1 ± 0.2. Heat in a water-bath prior to use and incubate at C under anaerobic conditions. B.4 Soya-bean casein digest medium Pancreatic digest of casein Papaic digest of soya-bean meal Sodium chloride Dipotassium hydrogen phosphate Glucose monohydrate/anhydrous Water R 17.0 g 3.0 g 5.0 g 2.5 g 2.5 g/2.3 g 1000 ml ph after sterilization 7.3 ± 0.2 B.4.1 Dissolve the solids in water R, warming slightly to effect solution. Cool the solution to room temperature. Add 1 M sodium hydroxide, if necessary, so that after sterilisation the solution will have a ph of 7.3 ± 0.2. B.4.2 Filter, if necessary, to clarify, distribute into suitable vessels and sterilise using a validated process. Store at a temperature between 2 C and 25 C in a sterile well-closed container, unless it is intended for immediate use. Do not use the medium for a longer storage period than has been validated. Soya-bean casein digest medium is to be incubated at C. The media used comply with the following tests, carried out before or in parallel with the test on the product to be examined. B.5 Sterility Incubate portions of the media for 14 days. No growth of micro-organisms occurs. UNBS 2018 All rights reserved 7

12 DUS 2011:2018 Annex C (informative) common surgical blade number C.1 Number 10 blade It has a large curved cutting edge. It is one of the more traditional blade shapes used for making large incisions and cuttings. C.2 Number 11 blade It is an elongated, triangular blade sharpened along the hypotenuse edge. It has a pointed tip making it ideal for stab incisions and precise short cuts in shallow recessed areas. C.3 Number 12 blade It is a small, pointed crescent-shaped blade sharpened along the inside edge of the curve. It is sometimes used as suture cutter. C.4 Number 15 blade It has a small curved cutting edge. It is ideal for making short precise incisions. C.5 Number 20 blade The No.20 is a large version of the No.10 blade with a curved cutting edge and a flat, unsharpened back edge. It is used for orthopaedic and general surgical procedures. C.6 Number 22 blade It is larger version of number 10 blade with curved cutting edge and flat unsharpened back edge. It is often used creating large incisions through thick skin. C.7 Number 23 blade The No.23 is a "leaf-shaped" blade sharpened along its leading edge. Used for making long incisions such as an upper midline incision of the abdomen during the repair of a perforated gastric ulcer. C.8 Number 24 blade Slightly larger than the No.23 blade, the No.24 is more semi-circular in shape and is again sharpened along its leading edge. Used for making long incisions in general surgery and also in autopsy procedures 8 UNBS 2018 All rights reserved

13 DUS 2011: 2018 C.9 Number 25 blade A front-facing straight blade with flat back Figure C 1 some illustrution for surgical blade number. UNBS 2018 All rights reserved 9

14 DUS 2011:2018 Annex D (informative ) Surgical blade parts Figure D General parts of a surgical blade. 10 UNBS 2018 All rights reserved

15 DUS 2011: 2018 Bibliography [1] ASTM A240/A240M 17, Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications [2] IS 3319, 1995, Blades, Surgical, Detachable (Bard Parker Type) and Handles - Specification (fourth revision) [3] ISO (both parts), Sterilization of health care products Ethylene oxide [4] ISO (all parts), Sterilization of health care products Radiation [5] ISO (all parts), Sterilization of health care products Moist heat [6] ISO 19000:2015, Quality management systems UNBS 2018 All rights reserved 11

16

17 DUS 2011: 2018 Certification marking Products that conform to Uganda standards may be marked with Uganda National Bureau of Standards (UNBS) Certification Mark shown in the figure below. The use of the UNBS Certification Mark is governed by the Standards Act, and the Regulations made thereunder. This mark can be used only by those licensed under the certification mark scheme operated by the Uganda National Bureau of Standards and in conjunction with the relevant Uganda Standard. The presence of this mark on a product or in relation to a product is an assurance that the goods comply with the requirements of that standard under a system of supervision, control and testing in accordance with the certification mark scheme of the Uganda National Bureau of Standards. UNBS marked products are continually checked by UNBS for conformity to that standard. Further particulars of the terms and conditions of licensing may be obtained from the Director, Uganda National Bureau of Standards. UNBS 2018 All rights reserved 13

18 DUS 2011: 2018 ICS Price based on nn pages UNBS 2018 All rights reserved