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ROAD VEHICLES - ROOF LOAD CARRIERS - PART 1: ROOF BARS (ISO 11154-1:1995, IDT)
MS ISO 11154-1:2005
Status : Original
Format : PDF

This Malaysian Standard specifies the minimum safety requirements for roof bars intended for mounting on or above the roofs of passenger cars or light commercial vehicles with a maximum authorized tot ....Read more al mass (ISO-M08) as defined in IS0 1176 up to 3.5 t. 
It applies to general-use roof bars suitable for carrying load, excluding magnetic and vacuum-fixed devices (see note I).

It establishes technical specifications and test methods which offer both the user of roof bars and road users a minimum level of safety when the roof bars are being used in accordance with the manufacturer’s instructions.
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Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests (ISO 11140-5:2007, IDT)
MS ISO 11140-5:2010 (CONFIRMED:2022)
Status : 2nd Confirmation
Format : PDF

This Malaysian Standard specifies the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre ....Read more -vacuum steam sterilization cycles. 
Additionally, this standard includes test methods and equipment used to meet these performance requirements.
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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES (ISO 11138-4:2006, IDT)
MS ISO 11138-4:2010
Status : Original
Format : PDF

This Malaysian Standard provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators, and test methods intended for use in assessing the performance of st ....Read more erilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C. 
NOTE: Requirements for work place safety may be provided by national or regional regulations.
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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES (ISO 11138-3:2006, IDT)
MS ISO 11138-3:2010
Status : Original
Format : PDF

This Malaysian Standard provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of ste ....Read more rilization processes employing moist heat as the sterilizing agent. 
Moist heat as the sterilizing agent is defined in this standard as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this Malaysian Standard might not be applicable for biological indicators used in such processes.

NOTE: National or regional regulations may provide requirements for work place safety.
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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES (ISO 11138-2:2006, IDT)
MS ISO 11138-2:2010
Status : Original
Format : PDF

This Malaysian Standard provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of ste ....Read more rilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.
NOTE: National or regional regulations could provide requirements for work place safety. 
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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 performance characteristics of biological indicators, including inoculated carriers and suspensions, a ....Read more nd 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.
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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, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of ste ....Read more rilization 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.
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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 radiation sterilization process for medical devices. 
NOTE: Although the scope of this st ....Read more andard 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
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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 procedures related to the development, validation and routine control of a radiation sterilization process a ....Read more re 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 ethylene oxide sterilization process for medical devices. Sterilization processes validated and ....Read more 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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