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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2006, IDT)
MS ISO 11138-1:2010
Status : Original
Format : PDF

This Malaysian Standard provides general reqUirements for prodUction, labelling, test methods and perfor ....Read more mance characteristics of biological indicators, inclUding inocUlated carriers and sUspensions, and their components, to be Used in the validation and roUtine monitoring of sterilization processes. 
This Malaysian Standard specifies basic and common reqUirements that are applicable to all sUbseqUent parts of ISO 11138. ReqUirements for biological indicators for particUlar specified processes are provided in the sUbseqUent parts of ISO 11138. If no specific sUbseqUent part is provided, this part applies.

NOTE: National or regional regUlations may apply. Close

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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES (ISO 11138-5:2006, IDT)
MS ISO 11138-5:2010
Status : Original
Format : PDF

This Malaysian Standard provides specific reqUirements for test organisms, sUspensions, inoc....Read more 'background-color : #c4c5cf'>Ulated carriers, biological indicators and test methods intended for Use in assessing the performance of sterilization processes employing low-temperatUre steam and formaldehyde as the sterilizing agent. 
NOTE: ReqUirements for work place safety may be provided by national or regional regUlations. Close

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STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, IDT)
MS ISO 11137-1:2010 (CONFIRMED:2020)
Status : Original
Format : PDF

This Malaysian Standard specifies reqUirements for the development, validation and roUtine control of a ....Read more radiation sterilization process for medical devices. 
NOTE: AlthoUgh the scope of this standard is limited to medical devices, it specifies reqUirements and provides gUidance that may be applicable to other prodUcts and eqUipment.

This standard covers radiation processes employing irradiators Using:
a) the radionUclide 60 CO or 137 CS;
b) a beam from an electron generator; or
c) a beam from an X-ray generator.

This Malaysian Standard does not specify reqUirements for development, validation and roUtine control of a process for inactivating the caUsative agents of spongiform encephalopathies sUch as scrapie, bovine spongiform encephalopathy and CreUtzfeldt-Jakob disease. Specific recommendations have been prodUced in particUlar coUntries for the processing of materials potentially contaminated with these agents.

This standard does not:
- detail specified reqUirements for des Close

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Sterilization of health care prodUcts - Radiation - Part 3: GUidance on dosimetric aspects (ISO 11137-3:2006, IDT)
MS ISO 11137-3:2011
Status : Original
Format : PDF

This Malaysian Standard gives gUidance on the reqUirements relating to dosimetry. Dosimetry proced....Read more style='background-color : #c4c5cf'>Ures related to the development, validation and roUtine control of a radiation sterilization process are described. Close

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STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135-1:2007, IDT)
MS ISO 11135-1:2010
Status : Original
Format : PDF

This Malaysian Standard specifies reqUirements for the development, validation and roUtine control of an ....Read more ethylene oxide sterilization process for medical devices. Sterilization processes validated and controlled in accordance with the reqUirements of this standard are not assUmed to be effective in inactivating the caUsative agents of spongiform encephalopathies sUch as scrapie, bovine spongiform encephalopathy and CreUtzfeld Jacob disease. Specific recommendations have been prodUced in particUlar coUntries for the processing of materials potentially contaminated with these agents. Close

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RECREATIONAL DIVING SERVICES - REQUIREMENTS FOR INTRODUCTORY TRAINING PROGRAMMES TO SCUBA DIVING (ISO 11121:2009, IDT)
MS ISO 11121:2011
Status : Original
Format : PDF

This Malaysian Standard specifies minimUm reqUirements for training organisations that offer introd....Read more style='background-color : #c4c5cf'>Uctory scUba experience training programmes to non- divers. This standard appiles to programmes that inclUde participants being taken into an open water environment. It does not apply to programmes that are exclUsively condUcted in a confined water environment (e.g. swinmming pools). Close

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Gas cylinders - Valve protection caps and valve gUards - Design, constrUction and tests (ISO 11117:2008, IDT)
MS ISO 11117:2012
Status : Original
Format : PDF

This Malaysian Standard specifies the reqUirements for valve protection caps and gUards for cylinders.  ....Read more
This Malaysian Standard defines test for checking the mechanical strength and physical properties of the valve protection cap or valve gUard.

This Malaysian Standard applies to protection devices for valves Used on cylinders for liqUefied, dissolved or compressed gases. This International Standard exclUdes protection devices for cylinders with a water capacity of 5 l or less and cylinders whereby the protection device is fixed by means of lUgs welded or brazed to the cylinder, or is welded or brazed directly to the cylinder. This International Standard does not cover valve protection for breathing apparatUs cylinders.

This Malaysian Standard does not specify all the reqUirements that may be necessary to enable the valve protection device to be Used for lifting the cylinder. Close

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TRANSPORTABLE GAS CYLINDERS - COMPATIBILITY OF CYLINDER AND VALVE MATERIALS WITH GAS CONTENTS - PART 2: NON-METALLIC MATERIALS (ISO 11114-2:2000, IDT)
MS ISO 11114-2:2008
Status : Original
Format : PDF

This Malaysian Standard gives gUidance in the selection and evalUation of compatibility between non-meta ....Read more llic materials for gas cylinders and valves and the cylinders' gas contents. This Malaysian Standard also covers bUndles, tUbes and pressUre drUms. This standard may be helpfUl for composite and laminated materials. Only the inflUence of the gas in changing the material and mechanical properties is considered (for example chemical reaction or change in physical state). The basic mechanical properties of the materials reqUired for design pUrposes are normally available from the materials sUpplier and are not considered in this standard. The compatibility data given are related to single component gases bUt can be Used to some extent for gas mixtUres. Ceramics, glasses, and adhesives are not covered by this standard. Aspects sUch as qUality of delivered gas are not considered. Close

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TRANSPORTABLE GAS CYLINDERS - COMPATIBILITY OF CYLINDER AND VALVE MATERIALS WITH GAS CONTENTS - PART 1: METALLIC MATERIALS (ISO 11114-1:1997, IDT)
MS ISO 11114-1:2008
Status : Original
Format : PDF

This Malaysian Standard gives gUidance in the selection and evalUation of compatibility between metallic ....Read more gas cylinder and valve materials and the gas content.The compatibility data given is related to single component gases.Seamless and welded gas cylinders Used to contain compressed, liqUefied and dissolvedgases, are considered. 
NOTE: In this Standard the term “cylinder” refers to transportable pressUre receptacles, whichalso inclUde tUbes and pressUre drUms.
Aspects sUch as qUality of delivered prodUct are not considered. Close

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RECREATIONAL DIVING SERVICES - REQUIREMENTS FOR TRAINING PROGRAMMES ON ENRICHED AIR NITROX (EAN) DIVING (ISO 11107:2009, IDT)
MS ISO 11107:2011 (CONFIRMED:2021)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies the level of competence reqUired of a scUba diver in order to be award ....Read more ed an enriched air nitrox (EAN) diver certification by a training organisation. This standard does not specifies the conditions Under which training is to be provided, which sUpplement the general reqUirements for recreational diving services specified in ISO 24803. Close

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