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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 product contact surfaces of the equipment used in the manufacture of sterile health care products ....Read more 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, programmes and procedures for development, validation and routine control of the manufacturing proces ....Read more s 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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Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005, IDT)
MS ISO 13408-6:2011
Status : Original
Format : PDF

This Malaysian Standard specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isol ....Read more ator systems used for aseptic processing of health care products. 
This standard is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials. Close

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Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003, IDT)
MS ISO 13408-2:2011
Status : Original
Format : PDF

This Malaysian Standard specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements ....Read more for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products. 
This Malaysian Standard is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines). Close

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Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006, IDT)
MS ISO 13408-3:2011 (CONFIRMED:2020)
Status : Original
Format : PDF

This Malaysian Standard specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It d ....Read more oes not address the physical/chemical objectives of a lyophilization process. Close

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Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2008, IDT)
MS ISO 13356:2011
Status : Original
Format : PDF

This Malaysian Standard specifies the characteristics of, and corresponding test methods for, a biocompatible and biostable ceramic bone-substitute material based on yttria-stabilized tetragonal zirco ....Read more nia (yttria tetragonal zirconia polycrystal, Y-TZP) for use as material for surgical implants. Close

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TRANSPORTABLE GAS CYLINDERS - FITTING OF VALVES TO GAS CYLINDERS (ISO 13341:1997, IDT)
MS ISO 13341:2008
Status : Original
Format : PDF

This Malaysian Standard specifies the essential procedures to be followed when connecting cylinder valves to gas cylinders. It applies to all valve and cylinder combination connected with screw thread ....Read more s but excludes breathing apparatus, diving gas cylinders and fire extinguihers. It defines routines for inspection and preparation prior to valving for both taper and parallel screw threads.
Torque values are given in annex A for steel and aluminium gas cylinders. Close

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Iron ores - Determination of zinc content - Flame atomic absorption spectrometric method (ISO 13310:1997, IDT)
MS ISO 13310:2004 (CONFIRMED:2013)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies a flame atomic absorption spectrometric method for the determination of the zinc content of iron ores. 
This method is applicable to zinc contents between 0,00 ....Read more 1 % (m/m) and 0,5 % (m/m) in natural iron ores, iron ores concentrates and agglomerates, including sinter products. Close

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Silica fume for concrete - Part 1: Definitions, requirements and conformity criteria
MS EN 13263-1:2017
Status : Original
Format : PDF

This Malaysian Standard applies to the silica fume which is a by-product of the smelting process used to produce silicon metal and ferro-silicon alloys. 
This standard gives requirements for ch ....Read more emical and physical properties for silica fume to be used as a type II addition in concrete conforming to MS 523-3 : 2010, or in mortars, grouts and other mixes.
This standard also states conformity criteria and related rules. Close

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Silica fume for concrete - Part 2: Conformity evaluation
MS EN 13263-2:2017
Status : Original
Format : PDF

This Malaysian Standard specifies the scheme for the evaluation of conformity of silica fume to EN 13263-1, including certification of conformity by a certification body. 
This standard provide ....Read more s technical rules for production control by the manufacturer, including autocontrol testing of samples, and for the tasks of the certification body. It also provides rules for actions to be followed in the event of non-conformity and the procedure for the certification of conformity. Close

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