CKS 312:2009 Edition 2.1 CKS. Umbilical cord fasteners ISBN
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1 ISBN CKS Umbilical cord fasteners This document does not have the status of a South African National Standard. Published by SABS STANDARDS DIVISION
2 Notice Except for purposes of tender or contract, no person may claim or create the impression that commodities comply with this specification. Table of changes Change No. Date Scope Amdt Amended to change the designation of SABS standards to SANS standards, and to update referenced standards and the definition of "acceptable". Foreword This coordinating specification is a technical agreement developed in accordance with SANS 1-1, and approved by National Committee SABS/TC 038/SC 03, Textiles Medical textiles. This document was published in May This document supersedes CKS 312:1993 (first revision). A vertical line in the margin shows where the text has been technically modified by amendment No. 1. Reaffirmed and reprinted in July This standard will be reviewed every five years and be reaffirmed, amended, revised or withdrawn. Obtainable from SABS Standards Division Private Bag X191 Pretoria Republic of South Africa 0001 Telephone : Fax : sales@sabs.co.za Website : COPYRIGHT RESERVED Printed in the Republic of South Africa by the SABS Standards Division
3 Umbilical cord fasteners 1 Scope This specification covers plastics umbilical cord clamps and three types of cotton tape suitable for use as umbilical cord ties. 2 Normative references The 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 international standards can be obtained from the SABS Standards Division. SANS 70, Conditioning of textiles and standard temperate atmosphere for determining their physical and mechanical properties. SANS 84, Length of fabric in a piece or roll. SANS 5003, The determination of the sterility of liquids and solid materials. SANS 5312, Number of interlacing threads in a braid. SANS 5314, Plaits per centimetre in a textile braid. SANS 5330, Mass per unit length of conditioned textile fabrics. SANS 5488, Width of ribbons and other narrow fabrics. SANS /ISO , Textiles Woven fabrics Construction Methods of analysis Part 2: Determination of number of threads per unit length. Amdt 1 SANS 10004, Terms and definitions for textiles and textile merchandise. SANS /ISO , Textiles Tensile properties of fabrics Part 1: Determination of maximum force and elongation at maximum force using the strip method. Amdt 1 1
4 3 Definitions For the purposes of this specification, the definitions given in SANS and the following definitions apply: 3.1 acceptable acceptable to the authority administering this specification, or to the parties concluding the purchase contract, as relevant Amdt umbilical cord fastener either a cotton tape or a plastics clamp suitable for the occlusion of umbilical cord vessels without danger of further bleeding 4 Requirements for umbilical cord ties 4.1 General The tape constituting an umbilical cord tie shall: have been made in accordance with sound manufacturing practice from clean, evenly spun cotton yarns; be bleached; be free from defects that might affect its appearance or impair its serviceability (or both); be of acceptably uniform make, width and finish; and be delivered in a clean and commercially dry condition. 4.2 Туре The tape shall be a woven type 30 or type 20 tape, or a braided type 23 tape in accordance with table 1, as required. 4.3 Length The tape in each individual container (see 6.1.1) shall be in one continuous length and shall, unless otherwise required, be of nominal length 20 m. Provided the average length of the tape in all the packages in a consignment is not less than the required length, the length of tape in individual containers may be subject to a tolerance of ± 5 %. 2
5 Table 1 Tape requirements Property Requirement Woven tape Braided tape Type 30 Type 20 Type 23 Test method subclause Composition 1) All cotton 7.3 Width, mm 7.4 min.... max Weave... Plain 2/2 pointed twill 7.5 on 11 ends Mass per unit length (free from nonfibrous material) g/100 m, min Number of threads Ends in full width... Picks per cm ) 9 Number of plaits per cm, min Number of carriers, min Total number of threads, min Breaking strength, N, min Fluorescence... Not more than an occasional point of intense blue fluorescence 7.12 Resistance to steam sterilization... There shall be no appreciable deterioration in handle ) 2) In the case of woven tapes produced on shuttleless looms, the selvedge locking thread may be of a fibre other than cotton. Except that in the case of tape woven on a shuttleless loom, this value shall be Requirements for umbilical cord clamps 5.1 General The clamp shall have been made in accordance with sound manufacturing practice from an acceptable plastics material, not contain any substance known to be toxic or an irritant, and be free from defects that might affect its appearance or impair its serviceability (or both). 3
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