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 978-0-626-21428-9 SANS 10213:2008Edition 3SOUTH AFRICAN NATIONAL STANDARD The installation and safe use of ethylene oxide (EO) sterilizers in health
4、care facilities and in industry 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 10213:2008 Edition 3 Table of changes Change No. Date Scope Foreword This South African standard was appr
5、oved by National Committee SABS SC 1039D, Medical devices Sterilization of healthcare products, in accordance with procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This document was published in October 2008. This document supersedes SABS 0213:1997 (sec
6、ond edition). A reference is made in 6.1 to general requirements for safe operating practice in compliance with “the current relevant national legislation”. In South Africa this means the Occupational Health and Safety Act, 1993 (Act No. 85 of 1993). Annexes A, B, C, D, E, F and G are for informatio
7、n only. SANS 10213:2008 Edition 3 1 Contents Page Foreword 1 Scope 3 2 Normative references . 3 3 Definitions . 3 4 Design, construction and installation of EO sterilization facilities 5 5 Maintenance . 8 6 Safe operating practice . 8 7 Checking of installation, and environment and personnel monitor
8、ing . 12 8 Personnel training . 13 9 Medical checks . 13 10 Permissible exposure limit 13 11 Assurance of compliance 14 12 Essential records 14 Annex A (informative) Anti-explosion safeguards for areas housing EO sterilizer installations . 15 Annex B (informative) Recommended emergency first-aid pro
9、cedures to be followed after accidental exposure of personnel to EO liquid or EO gas 16 Annex C (informative) Recommendations regarding the medical examination of personnel who regularly work with EO sterilizers 17 Annex D (informative) Information on EO monitoring and EO monitoring equipment 18 Ann
10、ex E (informative) Guidelines for aerating EO sterilized items in a healthcare facility . 21 Annex F (informative) Guidelines for materials that are impervious to EO . 22 Annex G (informative) Properties of EO 23 Bibliography 24 SANS 10213:2008 Edition 3 2 This page is intentionally left blank SANS
11、10213:2008 Edition 3 3 The installation and safe use of ethylene oxide (EO) sterilizers in healthcare facilities and in industry 1 Scope This standard covers the procedure for the installation of ethylene oxide (EO) sterilizers and the safety precautions and system management necessary for the safe
12、use of EO sterilizers in healthcare facilities and in industry. NOTE 1 Anti-explosion safeguards for areas housing EO sterilizer installations are given in annex A. NOTE 2 Recommended emergency first-aid procedures to be followed after accidental exposure of personnel to EO liquid or EO gas are give
13、n in annex B. NOTE 3 Recommendations regarding the medical examination of personnel who regularly work with EO sterilizers are given in annex C. NOTE 4 Information on EO monitoring and EO monitoring equipment is given in annex D. NOTE 5 Guidelines for aerating EO sterilized items in a healthcare fac
14、ility are given in annex E. NOTE 6 Guidelines for materials that are impervious to EO are given in annex F. NOTE 7 Properties of EO are given in annex G. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the e
15、dition 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 10108, The classification of hazardous locations
16、and the selection of apparatus for use in such locations. 3 Definitions For the purposes of this document, the following definitions apply: 3.1 bioburden population of viable micro-organisms on a product or on a package (or both) SANS 10213:2008 Edition 3 4 3.2 decontamination process of reducing bi
17、oburden before sterilization or disposal 3.3 dedicated designed or required (or both) to be used for a particular purpose only, for example, the venting of EO NOTE This can be descriptive of a room, an area, an item of equipment, or a system. 3.4 EO leak event that results or is likely to result in
18、a release of EO that can significantly contaminate areas other than the immediate area of the leak 3.5 EO spill event that results or is likely to result in a release of EO that can significantly contaminate areas other than the immediate area of the spill 3.6 equivalent 8 h time-weighted average TW
19、A8 sum of the individual EO concentrations in L/L multiplied by the corresponding exposure time in hours, for the total potential exposure period being considered (usually a full working shift), divided by eight NOTE X L/L is equivalent to X parts per million. 3.7 exhaust hood inlet designed to capt
20、ure EO contaminated air and to conduct the air into a dedicated exhaust ventilation system 3.8 healthcare facility places (sites) where professional health services are dispensed to patients or where biological research is carried out SANS 373-1:2006 3.9 local exhaust system non-circulating exhaust
21、ventilation system (comprising an exhaust hood or hoods, ductwork and an exhaust fan) that is intended to remove air and air contaminants from a particular localized area NOTE This area can be a single room, a specific site in a room, or an area on or above a single piece of equipment. 3.10 vent dis
22、charge or escape of gas that contains EO, via a tube, a pipe or a duct SANS 10213:2008 Edition 3 5 4 Design, construction and installation of EO sterilization facilities 4.1 Exhaust ventilation systems General requirements The design and construction of an EO exhaust ventilation system shall comply
23、with the following provisions: a) the sterilizer and the aerator unit shall have exhaust vent lines and they shall be vented in accordance with the manufacturers written instructions; b) the discharge end of the EO vent line shall be above ground level, at least 8 m clear of any building air-inlet a
24、nd away from pedestrian traffic or any source of ignition, or the discharge gases shall be routed through a suitable scrubber; c) all EO vent lines shall be constructed of material that is impervious to EO (see annex F), the lines shall be properly installed and they shall be dedicated; d) each EO v
25、entilation system shall include a failure alarm system; e) all electrical apparatus housed in the ventilation gas path shall be suitable for use in a class I, zone 1 location referred to in SANS 10108 and shall comply with the relevant recommendations given in SANS 10108; and f) fans used in the sys
26、tem shall be constructed of materials that are impervious to EO (see annex F). 4.2 Local exhaust systems 4.2.1 Application 4.2.1.1 A dedicated local exhaust system (including an exhaust hood) or any other system proven to be effective shall, when relevant, be provided for: a) the area immediately ab
27、ove the EO sterilizer door; b) the EO sterilizer pressure relief valve; c) the EO gas cylinder connection area; and d) the area above a sanitary sewer drain that is used for discharging EO effluent. 4.2.1.2 If the sterilizer is designed to sterilize at pressures below the ambient atmospheric pressur
28、e, it shall be permissible, as an alternative to the provisions of 4.2.1.1(a), to provide a dedicated local exhaust system with intakes positioned inside the sterilizer chamber that are so designed that: a) it is not possible to open the sterilizer door without automatically causing the sterilizer c
29、hamber exhaust system to operate; and b) the exhaust air flow rate is at least 15 m3per minute per square metre of door opening. SANS 10213:2008 Edition 3 6 4.2.2 Exhaust hoods An exhaust hood (where applicable) of a local exhaust system shall: a) be located as close as possible to the relevant sour
30、ce of EO contaminated air; and b) have a mean air capture velocity, measured over the face of the exhaust hood, of at least 0,5 m/s. 4.2.3 Exhaust hoods above sterilizer doors When relevant (see 4.2.1.1(a), and in the absence of any other suitable system, the exhaust hood positioned immediately abov
31、e the EO sterilizer door shall be capable of providing an exhaust air flow rate of at least 30 m3/min/m2of door opening or the rate specified by the manufacturer. 4.3 EO bulk liquid storage A compartment or a room that is used to store EO flammable liquid shall have a ventilation system capable of e
32、ffecting at least 20 total volume (excluding the space occupied by the containers) air changes per hour with air extraction intakes at positions close to floor level. 4.4 Areas housing gas cylinders 4.4.1 Storage areas 4.4.1.1 Each area that is designated for the storage of EO gas or EO gas mixtures
33、 in cylinders shall: a) comply with relevant building codes and local regulations; b) be so designed that the temperature in the storage area can be kept within the temperature range recommended by the gas supplier or sterilizer manufacturer, and that the cylinders are not exposed to direct sunlight
34、; c) have a ventilation system capable of effecting at least 20 total volume (excluding the space occupied by the cylinders) air changes per hour with air extraction intakes being at levels that include at least one air extraction intake near floor level, and one more at other levels, for example, c
35、lose to floor level, at breathing zone level and at a higher level; and d) not be used to store cylinders that contain oxygen, nitrous oxide or chlorine. 4.4.1.2 As an alternative to 4.4.1.1(c), if EO gas or EO gas mixtures in cylinders are stored outside a building, the storage area may be naturall
36、y ventilated, provided that a) the enclosure that surrounds the storage area has sufficient ventilation openings down to floor level on three sides to provide adequate ventilation, and b) the enclosure has, in a prominent position at the entrance, a warning sign bearing the information specified in
37、4.4.2(b). SANS 10213:2008 Edition 3 7 4.4.2 Gas cylinder connection areas1)A compartment or a room shall be dedicated to house connected gas cylinders and to store full and discharged gas cylinders temporarily. The compartment or room shall: a) have a ventilation system capable of effecting at least
38、 20 total volume (excluding the space occupied by the cylinders) air changes per hour with air extraction intakes at positions close to floor level; b) have, in a prominent position at the entrance, a warning sign bearing the following information: DANGER ETHYLENE OXIDE HEALTH AND EXPLOSION HAZARD N
39、O SMOKING NO NAKED FLAMES AUTHORIZED PERSONNEL ONLY NOTE Appropriate symbols may be used. and c) only be fitted with light fittings and other electrical equipment (when installed) that comply with the relevant recommendations given in SANS 10108 for electrical apparatus installed in class I, zone 1
40、locations. 4.5 Areas housing EO sterilizers and aerators 4.5.1 Any room or dedicated area in which EO sterilizers or aerators (or both) are installed shall have a volume of not less than volume B or 27 m3, whichever is the greater. B equals 54A, equivalent to 8 800 L/L on sudden release, and A = (g
41、+ a)/4 where A is the rated EO installed capacity, in cubic meters; g is the EO installed gas chamber volume, in cubic meters; a is the EO aerator chamber volume, in cubic meters. 1) It is recommended that an emergency shower, an eye wash facility and emergency oxygen resuscitation equipment be inst
42、alled adjacent to the EO gas cylinder connection area to facilitate immediate first-aid application in the event of accidental high exposure to EO. SANS 10213:2008 Edition 3 8 4.5.2 The area(s) that surround EO sterilizers or aerators or the room(s) in which they are installed shall: a) be so design
43、ed and constructed that it (they) can be maintained at a negative air pressure with respect to the air in adjoining areas; b) have a ventilation system capable of effecting at least 20 total volume (excluding the space occupied by the sterilizer or aerator) air changes per hour with the hood vent sw
44、itched off; c) have the air inlets and outlets so arranged as to ensure reasonably even and uniform ventilation, with air extraction outlets being positioned at levels that include at least one air extraction outlet near ceiling level and more at other levels, for example, at a high level, at breath
45、ing zone level and close to floor level; and d) have, in a prominent position at the entrance or in the access way, a warning sign that complies with the provisions of 4.4.2(b). 4.6 Aeration facilities 4.6.1 Provision shall be made for all EO sterilized items to be properly aerated. 4.6.2 Aeration s
46、hall preferably take place in the sterilizer or alternatively in an aeration cabinet specifically designed for this function (i.e. a cabinet that allows air changes and controlled air flow and temperatures). The aeration cabinet shall preferably be in the same room as the sterilizer. 4.6.3 If ambien
47、t temperature aeration is unavoidable, an aeration area, segregated from general work areas and with limited access (see 6.5), shall be provided. The ambient temperature aeration room shall be adjacent to the sterilization area or room and the unaerated product shall not be transported through areas
48、 where activities not associated with EO sterilization are carried out. A warning sign that complies with the provisions of 4.4.2(b) shall be displayed in a prominent position at the entrance or in the access way to the aeration area. The air in the aeration area shall be maintained at a negative pr
49、essure with respect to the air in adjoining areas and the area shall have a ventilation system capable of effecting at least 20 total volume (excluding the space occupied by trolleys and packages) air changes per hour. NOTE Aeration, i.e. the reducing of residual EO levels, is performed to ensure user and operator safety. 5 Maintenance Policies and procedures that cover the routine daily maintenance and preventive maintenance of the EO installation shall be formally documented. These procedures shall be maintained by competent, well-trained personnel. The manufactur
