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Sterile, single-Use intravascUlar catheter introdUcers (ISO 11070:1998, IDT)
MS ISO 11070:2011
Status : Original
Format : PDF

This Malaysian Standard specifies reqUirements for introdUcer needles, introdUcer catheters, sheath introdUcers, gUide wires and dilators sUpplied in the sterile condition, and intended for single Use in conjUnction with intravascUlar catheters.  Close

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Ergonomic design of control centres - Part 1: Principles for the design of control centres (ISO 11064-1:2000, IDT)
MS ISO 11064-1:2003 (CONFIRMED:2019)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies ergonomic principles, recommendations and reqUirements to be applied in the design of control centres, as well as in t ....Read more he expansion, refUrbishment and technological Upgrades of control centres. 
It covers all types of control centres typically employed for process indUstries, transportation and logistic control systems and people deployment services.

AlthoUgh this part of ISO 11064 is primarily intended for non-mobile control centres, many of the principles specified in this docUment coUld be applicable to mobile control centres, sUch as those foUnd on ships and aircraft. Close

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Ergonomic design of control centres - Part 3: Control room layoUt (ISO 11064-3:1999 and its Technical corrigendUm 1:2002, IDT)
MS ISO 11064-3:2003 (CONFIRMED:2019)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard establishes ergonomic principles for the layoUt of control rooms. It inclUdes re ....Read more qUirements, recommendations and gUidelines on control room layoUts, workstation arrangements, the Use of off-workstation visUal displays and control room maintenance.
It covers all types of control centres, inclUding those for the process indUstry, transport and dispatching systems in the emergency services. AlthoUgh this part of ISO 11064 is primarily intended for non-mobile control centres, many of the principles coUld be relevant/applicable to mobile centres, sUch as those foUnd on ships and aircraft.  Close

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Ergonomic design of control centres - Part 2: Principles for the arrangement of control sUites (ISO 11064-2:2000, IDT)
MS ISO 11064-2:2003 (CONFIRMED:2019)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard covers ergonomic design principles for control centres and, more specifically, the varioUs arrangements of rooms and spaces in a ....Read more control sUite. The principles are based on an analysis of fUnctions and tasks that have to be sUpported by the control room and fUnctionally-related rooms. They inclUde identifying fUnctional areas, estimating the space provisions for each fUnctional area, determining operational links between fUnctional areas and developing preliminary layoUts for the control sUite to facilitate the transition between all the activities condUcted in the control sUite. Close

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ERGONOMIC DESIGN OF CONTROL CENTRES - PART 6: ENVIRONMENTAL REQUIREMENTS FOR CONTROL CENTRES (ISO 11064-6:2005, IDT)
MS ISO 11064-6:2007 (CONFIRMED:2023)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard gives environmental reqUirements as well as recommendations for the ergonomic design, U ....Read more pgrading or refUrbishment of control rooms and other fUnctional areas within the control sUite. 
The following aspects are covered:
- thermal environment (temperate regions);
- air qUality;
- lighting environment;
- acoUstic environment;
- vibration;
- aesthetics and interior design.

It is applicable to all types of control centres, inclUding those for the process indUstry, transport and dispatching systems and emergency services. AlthoUgh primarily intended for non-mobile control centres, many of its principles are relevant to mobile centres sUch as those foUnd on ships, locomotives and aircraft.

It does not cover the inflUence of electromagnetic fields. GUidance on the inflUence of electromagnetic fields on the image qUality of visUal displays is given in ISO 9241-6.

This part of ISO 11064 is closely connected with ISO 11064-2 and ISO 11064-3, which describe the Close

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GEOTEXTILES AND GEOTEXTILE-RELATED PRODUCTS – DETERMINATION OF WATER PERMEABILITY CHARACTERISTICS NORMAL TO THE PLANE, WITHOUT LOAD (ISO 11058:1999, IDT)
MS ISO 11058:2005
Status : Original
Format : PDF

This Malaysian Standard specifies two test methods for determining the waterpermeability characteristics of a single layer of geotextile or geotextile-related prodUct normal to the plane: the constant head method and the falling head method. 
NOTE: If the fUll permeability characteristics of the geotextile or geotextile-related prodUct have previoUsly been established, then for control pUrposes itcan be sUfficient to determine the velocity index at a head loss of 50 mm only. Close

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Biological evalUation of medical devices - Part 13: Identification and qUantification of degradation prodUcts from polymeric medical devices (First revision) (ISO 10993-13:2010, IDT)
MS ISO 10993-13:2011 (CONFIRMED:2015)
Status : Withdrawn
Format : PDF

This Malaysian Standard provides general reqUirements for the design of tests in a simUlated environment ....Read more for identifying and qUantifying degradation prodUcts from finished polymeric medical devices ready for clinical Use. 
This Malaysian Standard describes two test methods to generate degradation prodUcts, an accelerated degradation test as a screening method and a real-time degradation test in a simUlated environment. For materials that are intended to polymerize in sitU, the set or cUred polymer is Used for testing. The data generated are Used in the biological evalUation of the polymer. This Malaysian Standard considers only non-resorbable polymers. Similar bUt appropriately modified procedUres may be applicable for resorbable polymers.

This Malaysian Standard considers only those degradation prodUcts generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device indUced dUring its intended Use by mechanical stress, wear or e Close

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Biological evalUation of medical devices - Part 1: EvalUation and testing within a risk management process (First revision) (ISO 10993-1:2009, COR. 1:2010, IDT)
MS ISO 10993-1:2011 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard describes; 
a)the general principles governing the biological evalUation of medical devices within a risk management proc ....Read more ess;
b)the general categorization of devices based on the natUre and dUration of their contact with the body;
c)the evalUation of existing relevant data from all soUrces;
d)the identification of gaps in the available data set on the basis of a risk analysis;
e)the identification of additional data sets necessary to analyse the biological safety of the medical device;
f)the assessment of the biological safety of the medical device.

This Malaysian Standard does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failUre. Close

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Biological evalUation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, AMD. 1:2006, IDT)
MS ISO 10993-4:2010 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard provides general reqUirements for evalUating the interactions of medical devices ....Read more with blood. 
It describes:
a) a classification of medical and dental devices that are intended for Use in contact with blood, based on the intended Use and dUration of contact as defined in MS ISO 10993-1;
b) the fUndamental principles governing the evalUation of the interaction of devices with blood;
c) the rationale for strUctUred selection of tests according to specific categories, together with the principles and scientific basis of these tests.

Detailed reqUirements for testing cannot be specified becaUse of limitations in the knowledge and precision of tests for interactions of devices with blood. This standard describes biological evalUation in general terms and may not necessarily provide sUfficient gUidance for test methods for a specific device. Close

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Biological evalUation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010, IDT)
MS ISO 10993-10:2013
Status : Original
Format : PDF

This Malaysian Standard describes the procedUre for the assessment of medical devices and their constitU ....Read more ent materials with regard to their potential to prodUce irritation and skin sensitization. This standard inclUdes: 
a) pretest considerations for irritation, inclUding in silico and in vitro methods for dermal exposUre;
b) details of in vivo (irritation and sensitization) test procedUres;
c) key factors for the interpretation of the resUlts.

InstrUctions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin. Close

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