Main Categories

CSA Scope:
[Add the following]
This Standard applies to equipment intended to be installed or used in accordance with CSA C22.1, the Canadian Electrical Code, Part I.

IEC Scope:

This clause of Part 1 is replaced by the following.

This part of IEC 60335 deals with the safety of portable electric heating tools and similar appliances, their rated voltage being not more than 250 V including direct current (DC) supplied appliances and battery-operated appliances. 

Appliances not intended for normal household use, but which nevertheless can be a source of danger to the public, such as appliances intended to be used by laypersons in shops, in light industry and on farms, are within the scope of this standard.

Appliances that can also be used when mounted on a support are within the scope of this standard. Examples of appliances that are within the scope of this standard are

– branding tools;

– burning-in pens;

– conduit-soldering tools;

– dehorning tools;

– desoldering irons;

– firelighters;

– glue guns;

– heat guns;

– household film-welding appliances;

– paint strippers;

– plastic-cutting tools;

– soldering guns;

– soldering irons;

– stripping pliers;

– thermoplastic conduit-welding tools. 

As far as is practicable, this standard deals with the common hazards presented by appliances which are encountered by all persons in and around the home. However, in general, it does not in general take into account– persons (including children) whose

• physical, sensory or mental capabilities; or
• lack of experience and knowledge

prevents them from using the appliance safely without supervision or instruction;

– children playing with the appliance. 
Attention is drawn to the fact that

– for appliances intended to be used in vehicles or on board ships or aircraft, additional requirements can be necessary;

– in many countries additional requirements are specified by the national health authorities, the national authorities responsible for the protection of labour and similar authorities.

This standard does not apply to:

– hand-held motor-operated electric tools (IEC 60745 series, IEC 62841 series);

– transportable motor-operated electric tools (IEC 61029 series, IEC 62841 series);

– appliances intended exclusively for industrial purposes;

– appliances intended to be used in locations where special conditions prevail, such as the presence of a corrosive or explosive atmosphere (dust, vapour or gas);

– tools using high-frequency heating other than induction soldering irons;

– arc-welding equipment.

1 Scope

1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment. This document covers radiation processes employing irradiators using:

a) the radionuclide 60Co or 137Cs;

b) a beam from an electron generator; or

c) a beam from an X-ray generator.

1.2 This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.

NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.

1.2.1 This document does not specify requirements for designating a medical device as sterile.

NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.

1.2.2 This document does not specify a quality management system for the control of all stages of production of medical devices.

NOTE It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.

1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.

1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.

NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries.

1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices.

1 Scope

1.1 Inclusions This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents.

1.2 Exclusions

1.2.1 This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included (see B.12).

1.2.2 This document does not address setting specific endotoxin limit specifications.

1 Scope

1.1 Inclusions

1.1.1 This document provides requirements for the development, validation and routine monitoring and control of a low temperature sterilization process for medical devices using vaporized hydrogen peroxide (VH2O2) as the sterilizing agent.

1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, organizations performing process validation of VH2O2 sterilization, and organizations responsible for sterilizing medical devices.

NOTE VH2O2 sterilizers can be used in both health care and industrial facilities, and this document acknowledges the similarities and differences between the two applications.

1.2 Exclusions

1.2.1 Processes that use other sterilizing agents, or hydrogen peroxide solution in combination with other chemicals as the sterilizing agent are not addressed in this document.

NOTE See ISO 14937 for guidance on validation of such processes.

1.2.2 This document does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies, e.g. 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.

NOTE Some VH2O2 sterilizers have processes that demonstrate some level of inactivation of the causative agents of spongiform encephalopathies, e.g. scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob Disease. However, this inactivation is process, cycle, and test protocol specific, therefore this inactivation is outside the scope of this document, and no specific test methods are provided (see [14], [26], and [30] for more information).

1.2.3 This document does not specify requirements for designating a medical device as sterile. NOTE See for example EN 556–1 or ANSI/AAMI ST67.

1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of VH2O2 sterilization equipment.

NOTE For further information on safety, see examples in the Bibliography. National or regional regulations can also exist.

1.2.5 This document does not apply to the contents of contained product, i.e. product for which the environment within the sterilizer chamber during any stage of the sterilization process does not come into direct contact with the product, such as a solution in a sealed bottle.

1.2.6 This document does not cover hydrogen peroxide decontamination systems for use in rooms, enclosures or environmental spaces.

NOTE These decontamination systems operate at ambient conditions (e.g. temperature and pressure) and in general utilise an approach that is different to that of VH2O2 sterilization processes addressed in this document.