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 978-0-626-22295-6 SANS 373-2:2009Edition 1 SOUTH AFRICAN NATIONAL STANDARD Reprocessing of endoscopes Part 2: Rigid endoscopes, associated component
4、s and accessories Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 373-2:2009 Edition 1 Table of changes Change No. Date Scope Acknowledgement The SABS Standards Division wishes to ackno
5、wledge the valuable assistance derived from the publications of Standards Australia and Standards New Zealand. Foreword This South African standard was approved by National Committee SABS SC 1039E, Medical devices Healthcare devices and materials for use in clinics and hospitals, in accordance with
6、procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This document was published in July 2009. A reference is made in 3.14 to water that complies with “the local regulations for drinking water“. In South Africa this means the Water Services Act, 1997 (Act N
7、o. 108 of 1997). A reference is made in 4.3(g) to systems and procedures instituted in accordance with “the current relevant national legislation“. In South Africa this means the Occupational Health and Safety Act, 1993 (Act No. 85 of 1993) and the Health Act, 1977 (Act No. 63 of 1977). A reference
8、is made in 4.5.2.1(f) to the high-level disinfectants that comply with the requirements of “the current relevant national legislation“. In South Africa this means the Standards Act, 1993 (Act No. 29 of 1993). A reference is made in 4.5.2.1(k) to the “legislated control limits“ for concentrations of
9、airborne hazardous chemicals in the reprocessing area. In South Africa this means the Occupational Health and Safety Act, 1993 (Act No. 85 of 1993). SANS 373 consists of the following parts, under the general title Reprocessing of endoscopes: Part 1: Flexible endoscopes and accessories. Part 2: Rigi
10、d endoscopes, associated components and accessories. Annex B forms an integral part of this standard. Annex A is for information only. SANS 373-2:2009 Edition 1 1 Contents Page Acknowledgement Foreword 1 Scope . 3 2 Normative references . 3 3 Definitions 4 4 Requirements 6 4.1 Reprocessing environme
11、nt . 6 4.2 Storage 7 4.3 Training of personnel 7 4.4 Personal protective equipment 8 4.5 Responsibilities of the healthcare facility 8 5 General 10 5.1 Main components of rigid endoscopes 10 5.2 Handling precautions . 115.3 Operational check 125.4 Visual check. 12 6 Reprocessing of rigid endoscopes,
12、 associated components and EAs . 13 6.1 General 13 6.2 Cleaning and disinfection using a WD . 13 6.3 Manual cleaning in a designated area . 14 7 Sterilization methods used in the reprocessing environment 17 7.1 Preparation 17 7.2 Steam sterilization. 187.3 Flash steam sterilization 18 7.4 Chemical s
13、terilization 19 8 Storage 20 Annex A (informative) Types of machine-based processes using a WD. 21 Annex B (normative) Information to be supplied by the manufacturer of the endoscope, associated components and EAs 22 Bibliography. 23 SANS 373-2:2009 Edition 1 2 This page is intentionally left blank
14、SANS 373-2:2009 Edition 1 3 Reprocessing of endoscopes Part 2: Rigid endoscopes, associated components and accessories 1 Scope 1.1 This standard provides a code of practice for the preparation of rigid endoscopes, associated components and the reusable endoscopic accessories used with rigid endoscop
15、es, for reuse, using washer disinfectors, steam, or chemicals in the reprocessing environment. It covers the requirements for personnel responsible for reprocessing endoscopes and for the reprocessing environments in healthcare facilities. 1.2 It does not cover: items intended by the manufacturer to
16、 be destroyed after single patient use; procedures to handle spillages of chemicals used for sterilization or disinfection; details of commercially available products used for high-level disinfection or chemical sterilization; and validation and routine control of various sterilization methods or pr
17、ocedures. 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 c
18、urrently valid national and international standards can be obtained from the SABS Standards Division. SANS 15883-2/ISO 15883-2, Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware
19、, etc. SANS 17664/ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices. SANS 373-2:2009 Edition 1 4 3 Definitions For the purposes of this document, the following definitions apply. 3.1 associated components d
20、evices customized and indispensable for use with rigid endoscopes (for example, trocars (cannulae), sheaths with bridges and adaptors, and the light-guide cable) 3.2 autoclavable suitability for sterilization by steam within an autoclave without deterioration of functional or structural integrity of
21、 the item being sterilized 3.3 autoclave enclosure designed to generate or control the process whereby devices placed inside are sterilized by steam 3.4 cleaning solution solution capable of breaking down biological soils such as proteins, lipids, carbohydrates and mucopolysaccharides and has no pro
22、tein-fixing effect (for example, an enzymatic cleaning solution) 3.5 clean potable water unused potable water that is free from visible suspended matter or sediment 3.6 disinfection reduction of the number of viable micro-organisms on a product to a level previously specified as appropriate for its
23、intended further handling or use SANS 15883-1:2008 3.7 endoscope optic instrument used to visually examine the interior of a bodily organ or to perform therapeutic interventions or minimal access surgery 3.8 endoscopic accessories EAs devices used directly within or upon endoscopes to facilitate the
24、ir diagnostic or interventional capability 3.9 healthcare facility place (site) where professional health services are dispensed to patients or where biological research is carried out SANS 373-2:2009 Edition 1 5 3.10 high-level disinfectant HLD chemical agent, which, when used for a shorter exposur
25、e time than would be required for sterilization, kills all micro-organisms with the exception of high numbers of bacterial spores 3.11 list names and details of patients scheduled for endoscopic procedures in each endoscopic procedure room NOTE The endoscopic procedure room can be an operating theat
26、re. 3.12 load all the goods, equipment and materials that are put into a washer-disinfector at any one time for the purpose of cleaning and disinfecting it by an operating cycle SANS 15883-1:2008 3.13 minimum effective concentration MEC concentration of disinfectant which, under the stated condition
27、s of temperature and time, will meet the required microbial performance 3.14 potable water water that complies with the local regulations for drinking water (see foreword) intended for human consumption 3.15 reprocessing cleaning and high-level disinfection or cleaning and sterilization necessary to
28、 render an endoscope, associated components and reusable endoscopic accessories ready for reuse 3.16 self-disinfection cycle operating cycle under the control of the automatic controller, for use without any load in the washer-disinfector, which is intended to disinfect all liquid transport systems
29、piping, chamber(s), tanks and other components that come into contact with the water or solutions (or both) used for cleaning, disinfecting and rinsing the load NOTE This does not include disinfection of pipework between the disinfectant supply and the control valve, where single-use, multi-dose con
30、tainers are used to provide process chemicals for use in the washer-disinfector. SANS 15883-4:2008 3.17 sterilant antimicrobial agent capable of achieving sterilization by chemical means 3.18 sterilization reduction of more than 99,9999 % or 6 log10 of the micro-organisms present by means of physica
31、l, chemical, or mechanical methods, or by irradiation SANS 373-2:2009 Edition 1 6 SANS 10248-1:2008 3.19 thermolabile damaged by exposure to temperatures within the range used for thermal disinfection NOTE The minimum temperature for thermal disinfection specified in SANS 15883-1 is 65 C. SANS 15883
32、-4:2008 3.20 viable micro-organism micro-organisms, including viruses, which are capable of multiplication under specified culture conditions SANS 15883-1:2008 3.21 washer-disinfector WD machine intended to clean and disinfect medical devices and other articles used in the context of medical, dental
33、, pharmaceutical and veterinary practice SANS 15883-1:2008 4 Requirements 4.1 Reprocessing environment A reprocessing environment shall be provided to include: a) separate designated areas for performing endoscopic procedures, the manual cleaning of endoscopes, associated components and EAs, and the
34、 reprocessing of endoscopic equipment such as automated washing and disinfection, sterilization and chemical treatment; b) adequate ventilation that will exhaust toxic vapors and airborne pathogens; c) area for manual processing that includes tight-fitting lids over basins containing large volumes o
35、f chemical disinfectants (for example, glutaraldehyde), utility sinks or basins large enough to totally immerse endoscopes, associated components and EAs, and a supply of clean potable water for rinsing after manual cleaning or for use in an approved WD; d) designated facility equipped for hand wash
36、ing and drying; SANS 373-2:2009 Edition 1 7 e) storage areas or cases appropriate for the instruments; and f) separate means of transportation for dirty (used) and clean or disinfected endoscopes. 4.2 Storage 4.2.1 Storage areas Storage areas used to store reprocessed endoscopes, associated componen
37、ts and EAs shall be enclosed, and shall be free from dust, humidity and temperature fluctuations. 4.2.2 Customized padded carry cases 4.2.2.1 Customized padded carry cases shall not be used for the storage of nor for the transport of contaminated endoscopes sent for repair. 4.2.2.2 Used or contamina
38、ted endoscopes that cannot be reprocessed without further damage to the endoscope shall be at least pre-cleaned and wiped externally before being sent for repair. NOTE It is recommended that the interior of carry cases should be washed and autoclaved, or exposed to ethylene oxide when there is reaso
39、n to suspect contamination of the carry cases. 4.3 Training of personnel Institutionally developed, competency-based training dedicated to the reprocessing of endoscopes shall include: a) complete familiarization with the mechanical aspects of endoscopic equipment; b) information on the safe handlin
40、g of endoscopes; c) thorough background knowledge of the potential chemical and infectious hazards for patients and healthcare personnel associated with the reprocessing of endoscopes; d) thorough background knowledge of the potential for negative patient and healthcare personnel outcomes that resul
41、t from lapses in compliance with written reprocessing guidelines; e) thorough instruction on the technique for the handling and reprocessing of endoscopes, associated components and EAs for specific procedures; f) information on the safe handling of body fluid spills or spillages of the chemicals us
42、ed for reprocessing; and g) information on systems and procedures instituted in accordance with the current relevant national legislation (see foreword). NOTE 1 Endoscopes, associated components and EAs should be the responsibility of a specific person or persons and should not be delegated to perso
43、n(s) who do not have the appropriate credentials or training for the position. NOTE 2 Training of person(s) responsible for endoscope reprocessing should be documented and reviewed regularly. NOTE 3 When an emergency endoscopic procedure is done outside of normal working hours, someone with knowledg
44、e of the process for endoscope decontamination should be available to prepare and clean the equipment. SANS 373-2:2009 Edition 1 8 4.4 Personal protective equipment 4.4.1 Gloves 4.4.1.1 The gloves used shall be: a) impervious to the cleaning agents and biocides used; NOTE Single-use nitrile gloves a
45、re recommended. b) of adequate length to prevent skin exposure; c) of the correct size to fit the user; and d) latex-free for use by latex sensitive individuals. 4.4.1.2 A new set of gloves shall be used each time the reprocessed or unpackaged endoscopic equipment is removed from the sterilant or th
46、e sterilizer. 4.4.1.3 Gloves shall be discarded if cracked, peeling, punctured or when their ability to function as a barrier is compromised. 4.4.1.4 Hands shall be washed thoroughly with soap and water and dried before each donning and after removal of gloves. 4.4.2 Gowns or aprons 4.4.2.1 Gowns or
47、 aprons worn shall: a) be fluid repellant; b) provide full skin protection for arms and legs; and c) be changed if soiled. 4.4.2.2 Gowns used during endoscopic reprocessing shall be removed before leaving the designated reprocessing area. 4.4.3 Face and eye protection Face masks and protective eyewe
48、ar or face shields shall be appropriate to the task and adequate to protect the user from contact with reprocessing chemicals and potentially infectious material. 4.5 Responsibilities of the healthcare facility 4.5.1 Personnel 4.5.1.1 Pre-employment checks shall be carried out on prospective employe
49、es for health conditions that could be aggravated by exposure to chemicals used for sterilization and disinfection. 4.5.1.2 Personnel working with endoscopes shall be provided with: a) device-specific reprocessing instructions; b) regular follow-up competency tests; SANS 373-2:2009 Edition 1 9 c) instructions regarding safe working practices; d) regular health surveillance checks, preferably on an annual basis; e) immunization in accordance with the healthcare facility protocol; and f) adequate personal protective equipment. 4.5.2 Healthcare
