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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, upgrading or refurbishment of control rooms and other functional areas within the control ....Read more 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 ....Read more 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Status : Withdrawn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 for identifying and quantifying degradation products from finished polymeric medical devices re ....Read more ady 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 process;
b)the general categorization of devi ....Read more ces 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 with blood. 
It describes:
a) a classification of medical and dental devices that ....Read more 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 constituent materials with regard to their potential to produce irritation and skin sensitization. This ....Read more 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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Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000, IDT)
MS ISO 10993-15:2005 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding m ....Read more aterial samples finished as ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behavior in the body. The described chemical methodologies are a means to generate degradation products for further assessments. 
This Malaysian Standard is not applicable to degradation products induced by applied mechanical stress.

NOTE: Mechanically induced degradation, such as wear, may be covered in the appropriate product-specific standard. Where product-group standards provide applicable product-specific methodologies for the identification and quantification of deg Close

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Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009, IDT)
MS ISO 10993-5:2013
Status : Withdrawn
Format : PDF

This Malaysian Standard describes test methods to assess the in vitro cytotoxicity of medical devices. 
These methods specify the incubation of cultured cells in contact with a device and/or ex ....Read more tracts of a device either directly or through diffusion.

These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters. Close

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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES (ISO 10993-17:2002, IDT)
MS ISO 10993-17:2005 (CONFIRMED:2011)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies a method for the determination of allowable limits for substances leach able from medical devices. It is intended for use in deriving standards and estimating appropr ....Read more iate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. 
This Malaysian Standard is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).

Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This Malaysian Standard does not address the potential for exposure from such sources. Close

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Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001, IDT)
MS ISO 10993-14:2005 (CONFIRMED:2015)
Status : 1st Confirmation
Format : PDF

This Malaysian Standard specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the analysi ....Read more s of these solutions in order to identify the degradation products. Because of the generalized nature of this standard, product specific standards, when available, that address degradation product formation under more relevant conditions of use, should be considered first. 
This Malaysian Standard considers only those degradation products generated by a chemical dissociation of ceramics during in vitro testing. No degradation induced by mechanical stress or external energy is covered.

Because of the range of ceramics used in medical devices and the different requirements for accuracy and precision of the results, no specific analytical techniques are identified.

Although these materials are intended for biomedical applications, the biological activity of these degradation products is n Close

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