M/481 - Household dishwasher

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use.
This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for self-testing.

This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is without appreciable harm are also specified. The toxicological risk assessment can be part of the biological evaluation of the final product, as described in ISO 10993-1.
The process described in this document applies to chemical characterization information obtained in line with ISO 10993-18. When a toxicological risk assessment of either the compositional information or analytical chemistry data (e.g. extractable data or leachable data) are required to determine whether the toxicological risks related to the constituents are negligible or tolerable.
The process described in this document is not intended to apply to circumstances where the toxicological risk has been estimated by other means, such as:
—    constituents, excluding cohort of concern or excluded chemicals, that are present in or extracted from a medical device at an amount representative of patient exposure below a relevant, toxicologically-based reporting threshold (see applicable requirements in ISO 10993-18:2020, Annex E and ISO/TS 21726);
—    a new or changed medical device for which chemical or biological equivalence has been established with an existing biocompatible or clinically established medical device (see applicable requirements in ISO 10993-18:2020, Annex C).
The process described in this document is also not applicable to:
—    medical device constituents that do not contact the body (e.g. in vitro diagnostics);
—    biological risks associated with physical interactions of the medical device with the body (i.e. application of mechanical forces, energy or surface morphology, etc.), provided that the chemical exposure is not changed;
—    active pharmaceutical ingredients of device-drug combination products or biologic components of device-biologic combination products as additional regulatory considerations can apply;
—    exposure to a particular constituent that arises from sources other than the device, such as food, water or air.

This document is applicable to all types of fluid heating solar collectors. This document specifies performance requirements for fluid heating solar collectors with respect to durability, reliability, safety and thermal performance.
This document deals with the solar collector and not with assemblies. This document is not applicable to those devices in which a thermal storage unit is an integral part to such an extent that the collection process cannot be separated from the storage process for making the collector thermal performance measurements.

This document specifies general requirements for motorcyclists’ protective garments of Class C, worn as under or overgarments, intended to provide limited protection to the wearer against impact injury. It applies to protective garments for motorcycle on-road use.

This document specifies general requirements for motorcyclists’ protective garments of Class C, worn as under or overgarments, intended to provide limited protection to the wearer against impact injury. It applies to protective garments for motorcycle on-road use.

- The scope of the standard to be amended is:
This European Standard specifies the safety requirements applicable to carriers for cableway installations designed to carry persons. This part of EN 12929 specifies the safety requirements for the general requirements for cableway installations designed to carry persons. These requirements are applied to the various types of installations and their environment.
This document defines general technical characteristics and prescribes design principles and general safety requirements.
It does not deal with details of operation and maintenance, nor with calculations and detailed requirements for the manufacture of components.
This Part 1 does not deal with special regulations applicable to bi-cable reversible aerial ropeways without carrier truck brakes, which are the subject of Part 2.
It includes requirements relating to the prevention of accidents and the protection of workers.
It does not apply to cableway installations for transportation of goods or to lifts.
Clause 11 describes the minimum requirements to be normatively satisfied for passageways and work areas. National regulations of a building or federal/state nature or which serve to protect particular groups of people remain unaffected.
It may not always be possible for all types of cableway installation to transport all particular groups of people (e.g. persons with restricted mobility). The objective should be, however, for a cableway installation to enable the transportation of the largest possible passenger population.
- The scope of the proposed amendment A1 on this standard is to modify article 10.2 on braking system in order to be in line with the text of the regulation 2016/424/

- The scope of the standard to be amended is:
This European Standard specifies the safety requirements applicable to carriers for cableway installations designed to carry persons. This part of EN 12929 specifies the safety requirements for the general requirements for cableway installations designed to carry persons. These requirements are applied to the various types of installations and their environment.
This document defines general technical characteristics and prescribes design principles and general safety requirements.
It does not deal with details of operation and maintenance, nor with calculations and detailed requirements for the manufacture of components.
This Part 1 does not deal with special regulations applicable to bi-cable reversible aerial ropeways without carrier truck brakes, which are the subject of Part 2.
It includes requirements relating to the prevention of accidents and the protection of workers.
It does not apply to cableway installations for transportation of goods or to lifts.
Clause 11 describes the minimum requirements to be normatively satisfied for passageways and work areas. National regulations of a building or federal/state nature or which serve to protect particular groups of people remain unaffected.
It may not always be possible for all types of cableway installation to transport all particular groups of people (e.g. persons with restricted mobility). The objective should be, however, for a cableway installation to enable the transportation of the largest possible passenger population.
- The scope of the proposed amendment A1 on this standard is to modify article 10.2 on braking system in order to be in line with the text of the regulation 2016/424/

This document deals with the technical requirements to minimise the risks of hazards listed in Clause 4 which can arise during the operation and/or maintenance of double acting hydraulic rescue tool systems, when carried out as intended by the manufacturer or his authorised representative.
All the safety requirements of this document apply to double acting hydraulic rescue tools manufactured after the date of publication.
Double acting hydraulic rescue tool systems are intended for use by the fire fighting and rescue services, principally for cutting through, spreading or pushing apart the structural parts of road vehicles, ships, trains, aircraft's and building structures involved in accidents. They consist, as defined in Clause 3 of a separate power pack, the tool[s] and the necessary interconnections and intended accessories.
NOTE 1   The aim is to assist whilst extracting the casualties or to create a working space for paramedical services taking the local conditions into account.
This document does not establish the additional requirements for:
a)   operation in severe conditions (e.g. extreme environmental conditions such as: temperatures outside the range -20 °C +55 °C, corrosive environment, tropical environment, contaminating environments, strong magnetic fields, potentially explosive atmospheres);
b)   the risk directly arising from the means provided for the portability, transportability and mobility of double-acting hydraulic rescue tools during periods of their operation.
NOTE 2   For the EU/EEA other Directives can be applicable to the equipment in the scope, for example the Electro Magnetic Compatibility Directive.

This document deals with the technical requirements to minimise the risks of hazards listed in Clause 4 which can arise during the operation and/or maintenance of double acting hydraulic rescue tool systems, when carried out as intended by the manufacturer or his authorised representative.
All the safety requirements of this document apply to double acting hydraulic rescue tools manufactured after the date of publication.
Double acting hydraulic rescue tool systems are intended for use by the fire fighting and rescue services, principally for cutting through, spreading or pushing apart the structural parts of road vehicles, ships, trains, aircraft's and building structures involved in accidents. They consist, as defined in Clause 3 of a separate power pack, the tool[s] and the necessary interconnections and intended accessories.
NOTE 1   The aim is to assist whilst extracting the casualties or to create a working space for paramedical services taking the local conditions into account.
This document does not establish the additional requirements for:
a)   operation in severe conditions (e.g. extreme environmental conditions such as: temperatures outside the range -20 °C +55 °C, corrosive environment, tropical environment, contaminating environments, strong magnetic fields, potentially explosive atmospheres);
b)   the risk directly arising from the means provided for the portability, transportability and mobility of double-acting hydraulic rescue tools during periods of their operation.
NOTE 2   For the EU/EEA other Directives can be applicable to the equipment in the scope, for example the Electro Magnetic Compatibility Directive.