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This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for ...view more

REN/ERM-TGMAR-604

This document specifies:
— the general principles governing the biological evaluation of medical devices within a risk management process;
— the general categorization of medical devices based on the nature and duration of their contact with the body;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of the...view more

DOP of 12 months

This document is applicable to lead-acid batteries powering electric two-wheelers (mopeds)
and three-wheelers (e-rickshaws and delivery vehicles), and also to golf cars and similar light
utility and multi-passenger vehicles.
a) operate them most often in an environment with many bystanders who are unaware of the
possible risks involved. The batteries have thus to be eminently reliable, consumer friendly
and minimize risks of fire, explosions, electrical shocks and chemical burns.
These bat...view more

This document defines the repeatability and the reproducibility of a method using near infrared spectroscopy in whole kernels for the determination of moisture and protein on wheat and barley. The performance of the method (accuracy) is found in EN 15948.
The values derived from the report are applicable to the following concentration ranges:
-  for wheat:
-   moisture content range from 9,5 % - 15,7 %;
-   protein content range from 10,0 % DM to 18,6 % DM;
-  for barley:
-   moisture content ra...view more

This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442‑1.
NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising ...view more

This document specifies requirements and tests for the product safety of secondary lithium
cells and batteries used in electrical energy storage systems (Figure 2) with a maximum DC
voltage of 1 500 V (nominal).
Basic safety requirements for the secondary lithium cells and batteries used in industrial
applications are included in IEC 62619. This document provides additional or specific
requirements for electrical energy storage systems.
Since this document covers batteries for various elec...view more

This document specifies safety tests and requirements for secondary lithium batteries
permanently installed in road vehicles not for the propulsion. Replacement secondary
batteries permanently installed in road vehicles not for propulsion are covered by this
document.
The following are typical applications that utilize the batteries under the scope of this
document: a power source for the starting of internal combustion engines, lighting, on-board
auxiliary equipment, and energy absorption...view more

This part of IEC 62984 specifies safety requirements and test procedures for high-temperature
batteries for mobile and/or stationary use and whose rated voltage does not exceed 1 500 V.
This document does not cover aircraft batteries, which are covered by IEC 60952 (all parts),
and batteries for the propulsion of electric road vehicles, covered by IEC 61982 (all parts).
NOTE High-temperature batteries are electrochemical systems whose cells' internal minimum operating
temperature is above 1...view more

This part of IEC 62932 specifies methods of test and requirements for the flow battery system
(FBS) and the flow battery energy system (FBES) for the verification of their performances.
This document is applicable to FBES or FBS which are designed and used for service in
stationary locations (i.e. not generally to be moved from place to place).
This document does not cover testing of the system for electromagnetic compatibility (EMC).

This document specifies safety requirements and test methods for baby walking frames into which a child is placed, and intended to be used from when the child is able to sit up by itself until the child is able to walk by itself.
This document does not apply to baby walking frames for therapeutic and curative purposes and to those baby walking frames relying on inflatable parts to support the child.
Toys (e.g. ride on toys, push-along toys, usually intended for children able to walk unaided) a...view more

IEC 62984-1:2020 specifies general aspects, definitions and tests for high-temperature secondary batteries for mobile and/or stationary use and whose nominal voltage does not exceed 1 500 V. This document does not cover aircraft batteries, which are covered by IEC 60952 (all parts), or batteries for the propulsion of electric road vehicles, covered by IEC 61982 (all parts).

This part of IEC 62932 relates to flow battery energy systems (FBES) used in electrical energy
storage (EES) applications and provides the main terminology and general aspects of this
technology, including terms necessary for the definition of unit parameters, test methods, safety
and environmental issues.

IEC 60384-13:2020 specifies preferred ratings and characteristics, selects from IEC 60384-1:2016 the appropriate quality assessment procedures, tests and measuring methods, and gives general performance requirements for this type of capacitor. Test severities and requirements specified in detail specifications referring to this sectional specification are of an equal or higher performance level. Lower performance levels are not permitted. This part of IEC 60384 applies to fixed direct current ca...view more