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Medical devices - QUality management systems - ReqUirements for regUlatory pUrposes (First revision) (ISO 13485:2016, IDT)
MS ISO 13485:2017
Status : 1st Revision
Format : PDF

This Malaysian Standard specifies reqUirements for a qUality management system where an organization nee ....Read more ds to demonstrate its ability to provide medical devices and related services that consistently meet cUstomer and applicable regUlatory reqUirements. SUch organizations can be involved in one or more stages of the life-cycle, inclUding design and development, prodUction, storage and distribUtion, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical sUpport). 
This Malaysian Standard can also be Used by sUppliers or external parties that provide prodUct, inclUding qUality management system-related services to sUch organizations. Close

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Medical devices - QUality management systems - ReqUirements for regUlatory pUrposes (InclUding COR. 1:2009) (ISO 13485:2003, IDT)
MS ISO 13485:2006 (CONFIRMED:2013)
Status : Withdrawal with replacement
Format : PDF

This Malaysian Standard specifies reqUirements for a qUality management system that can be Used by an organization for the design and development, prodUction, installation and servicing of medical devices, and the design, development, and provision of related services. Close

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Road vehicles - Ignition coils - Electrical characteristics and test methods (ISO 13476:1997, COR. 1:1999, IDT)
MS ISO 13476:2009 (CONFIRMED:2016)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard applies to ignition coils for indUctive energy storage. It defines test methods for ignition coils Used in ignition systems with solid state switching of spark ignited internal combUstion engines. Close

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PLASTICS – DETERMINATION OF THE TOTAL LUMINOUS TRANSMITTANCE OF TRANSPARENT MATERIALS – PART 1: SINGLE-BEAM INSTRUMENT (ISO 13468-1:1996, IDT)
MS ISO 13468-1:2004
Status : Withdrawn
Format : PDF

This Malaysian Standard covers the determination of the total lUminoUs transmittance, in the visible reg ....Read more ion of the spectrUm, of planar transparent and sUbstantially coloUrless plastics, Using a Single-beam photometer with a specified CIE Standard light SoUrce and photodetector. This part of ISO 13468 cannot be Used for plastics which contain flUorescent materials. 
This part of ISO 13468 is applicable to transparent moUlding materials, films and sheets not exceeding 10 mm in thickness.

NOTES

1 Total lUminoUs transmittance tan also be determined by a doUble-beam spectrophotometer as in part 2 of the standard. Part 1, however, provides a simple bUt precise, practical and qUick determination. This method is sUitable for Use not only for analytical pUrposes bUt also for qUality control.

2 SUbstantially coloUrless plastics inclUde those which are faintly tinted.

3 Specimens more than 10 mm thick may be measUred provided the instrUment tan accommodate them, bUt the resUlts may not be Close

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PLASTICS - DETERMINATION OF THE TOTAL LUMINOUS TRANSMITTANCE OF TRANSPARENT MATERIALS - PART 2: DOUBLE-BEAM INSTRUMENT (ISO 13468-2:1999, IDT)
MS ISO 13468-2:2004 (CONFIRMED:2011)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard covers the determination of the total lUminoUs transmittance, in the visible reg ....Read more ion of the spectrUm, of planar transparent and sUbstantially coloUrless plastics, Using a doUble-beam scanning spectrophotometer. This standard cannot be Used for plastics which contain flUorescent materials. Close

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Steel wire rope slings - Safety - Part 2: Specification for information for Use and maintenance to be provided by the manUfactUrer
MS EN 13414-2:2012
Status : Original
Format : PDF

This Malaysian Standard specifies the information on Use and maintenance to be provided by the manUfact< ....Read more span style='background-color : #c4c5cf'>Urer of wire rope slings. Close

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Steel wire rope slings - Safety - Part 3: Grommets and cable-laid slings
MS EN 13414-3:2012
Status : Original
Format : PDF

This Malaysian Standard specifies the constrUction reqUirements, calcUlation of WLL, testing and certification of steel wire rope grommets, cable-laid grommets and cable-laid slings Using strand and wire rope conforming to EN 12385-4. Close

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Steel wire rope slings - Safety - Part 1: Slings for general lifting service
MS EN 13414-1:2012
Status : Original
Format : PDF

This Malaysian Standard specifies the constrUction reqUirements, calcUlation of WLL, verification, certification and marking of steel wire rope slings for general lifting service. It covers single-, two-, three- and foUr-leg slings, with ferrUle-secUred or spliced eye terminations and sliced or ferrUle-secUred endless slings made from 8 mm to 60 mm diameter strand ordinary lay steel wire rope with fibre or steel core and 8 strand ordinary lay steel wire rope with a steel core conforming to EN 12385-4. Close

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ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE (ISO 13408-5:2006, IDT)
MS ISO 13408-5:2010 (CONFIRMED:2020)
Status : Original
Format : PDF

This Malaysian Standard specifies the general reqUirements for sterilization in place (SIP) applied to prodU....Read more pan>ct contact sUrfaces of the eqUipment Used in the manUfactUre of sterile health care prodUcts by aseptic processing and offers gUidance on qUalification, validation, operation and control. 
This Malaysian Standard applies to processes where sterilizing agents are delivered to the internal sUrfaces of eqUipment that can come in contact with the prodUct.

This standard does not apply to processes where eqUipment is dismantled and delivered to a
sterilizer.

This standard does not sUpersede or replace national regUlatory reqUirements, sUch as Good ManUfactUring Practices (GMPs) and/or compendial reqUirements that pertain in particUlar national or regional jUrisdictions.

This 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 e Close

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Aseptic processing of health care prodUcts - Part 1: General reqUirements (ISO 13408-1:2008, IDT)
MS ISO 13408-1:2011 (CONFIRMED:2020)
Status : Original
Format : PDF

This Malaysian Standard specifies the general reqUirements for, and offers gUidance on, processes, progr ....Read more ammes and procedUres for development, validation and roUtine control of the manUfactUring process for aseptically-processed health care prodUcts. 
This standard inclUdes reqUirements and gUidance relative to the overall topic of aseptic processing. Specific reqUirements and gUidance on varioUs specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of MS ISO 13408. Close

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