DIN EN ISO 18778:2009 PDF

Scope: IEC 60601-1:1988, Clause 1, applies except as follows: Amendments (add at end of 1.1): 1.1 This International Standard specifies requirements for the safety and essential performance of monitors used to detect apparent life-threatening events1) in sleeping or resting children under three years of age. This International Standard applies to devices used in home care applications. These monitors are generally used without continual professional supervision. This International Standard also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient. This International Standard does not apply to monitors intended for use in health care facilities/institutions. The requirements of this International Standard, which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995), are intended to take precedence over the corresponding general requirements. 1.4 Addition: NOTE Planning and design of products complying with this Standard can have environmental impact during the product life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmental impact are addressed in ISO 14971.

DIN EN ISO 18778:2009 Referenced Document

EN 71-1:1998 Safety of Toys - Part 1: Mechanical and Physical Properties (Incorporates Amendments A1: 2001 and A5: 2000)
EN 980:2003 Graphical Symbols for Use in the Labelling of Medical Devices
IEC 60068-2-32:1975 Basic environmental testing procedures. Part 2 : Tests. Test Ed: Free fall
IEC 60529:2001 Degrees of protection provided by enclosure (IP code)*， 2024-04-19 Update
IEC 60601-1-2:2001 Medical electrical equipment - Part 1-2: General requirements for safety; Collateral standard: Electromagnetic compatibility; Requirements and tests
IEC 60601-2-23:1999 Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary

2023 DIN EN ISO 18778:2023-02 Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors (ISO 18778:2022); German version EN ISO 18778:2022
2023 DIN EN ISO 18778:2023 Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors (ISO 18778:2022)
1970 DIN EN ISO 18778 E:2021-05 Respiratory equipment - Special requirements for basic safety and essential performance of infant cardiopulmonary monitors (draft)
2021 DIN EN ISO 18778 E:2021 Draft Document - Respiratory equipment - Particular requirements for basic safety and essential performance of equipment for infant cardiorespiratory monitors (ISO/DIS 18778:2021); German and English version prEN ISO 18778:2021
2009 DIN EN ISO 18778:2009 Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005); English version of DIN EN ISO 18778:2009-08
0000 DIN EN ISO 18778:2005