Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in bistvene lastnosti (IEC 60601-1:2005/AMD1:2012)

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Technical Committee
COVID 19 - COVID 19 - ISO
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standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK
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SIST COVID-19 SIST EN 60601-1:2007/A1:2014/AC:2015

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Frequently Asked Questions

SIST EN 60601-1:2007/A1:2014/AC:2015 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance". This standard covers: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

SIST EN 60601-1:2007/A1:2014/AC:2015 is associated with the following European legislation: EU Directives/Regulations: standardi COVID-19. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

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Standards Content (Sample)


Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
SLOVENSKI STANDARD
01-maj-2015
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ELVWYHQHODVWQRVWL ,(&$0'
Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale
Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et
les performances essentielles
Ta slovenski standard je istoveten z: EN 60601-1:2006/A1:2013/AC:2014
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

SIST EN 60601-1:200
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記事タイトル：SIST EN 60601-1:2007/A1:2014/AC:2015 - 医療電気機器 - 第1部：基本的な安全性と必須性能の一般的な要件 記事内容：この記事では、医療電気機器に関連するSIST EN 60601-1:2007/A1:2014/AC:2015規格について説明しています。この規格は、医療機器の基本的な安全性と必須性能に関する一般的な要件を定めています。電気的な安全性、機械的な危険からの保護、電磁障害による危険からの保護などの領域をカバーしています。この規格は、医療機関における医療電気機器の安全な使用を確保することを目的としています。

기사 제목: SIST EN 60601-1: 2007 / A1: 2014 / AC: 2015 - 의료 전기 장비 - 제1 부 : 기본 안전 및 필수 성능에 대한 일반 요구 사항 기사 내용: 기사는 의료 전기 장비에 대한 표준 사양에 대해 논의하고 있습니다. SIST EN 60601-1: 2007 / A1: 2014 / AC: 2015로 알려진 이 표준은 의료 장비의 기본 안전과 필수 성능에 대한 일반 요구 사항을 설명합니다. 전기적 안전, 방사선 보호, 기계적 강도 및 소프트웨어 유효성 검증과 같은 다양한 측면을 다룹니다. 이 표준은 의료 장비가 안전하고 필수 기능을 효과적으로 수행하는 것을 보장하기 위해 만들어졌습니다.

The article discusses the standard specification for medical electrical equipment. The standard, known as SIST EN 60601-1:2007/A1:2014/AC:2015, outlines the general requirements for basic safety and essential performance of medical equipment. It covers various aspects such as electrical safety, radiation protection, mechanical strength, and software validation. The standard aims to ensure that medical equipment is safe and performs its essential functions effectively.

記事のタイトル：SIST EN 60601-1:2007/A1:2014/AC:2015 - 医療電気機器 - 第1部：基本的な安全性と必須性能の一般要件 記事内容：この記事では、医療電気機器の標準仕様について説明しています。SIST EN 60601-1:2007/A1:2014/AC:2015として知られるこの標準は、医療機器の基本的な安全性と必須性能の一般的な要件について述べています。電気的安全性、放射線防護、機械的強度、ソフトウェアの検証など、さまざまな側面をカバーしています。この標準は、医療機器が安全で必須の機能を効果的に実行することを保証することを目的としています。

The article discusses the SIST EN 60601-1:2007/A1:2014/AC:2015 standard, which is related to medical electrical equipment. This standard specifies the general requirements for basic safety and essential performance of medical devices. It covers areas such as electrical safety, protection against mechanical hazards, and protection against hazards caused by electromagnetic disturbances. The standard aims to ensure the safe use of medical electrical equipment in healthcare facilities.

기사 제목: SIST EN 60601-1:2007/A1:2014/AC:2015 - 의료 전기 장비 - 제1부: 기본 안전과 필수 성능에 대한 일반 요구 사항 기사 내용: 이 기사는 의료 전기 장비와 관련된 SIST EN 60601-1:2007/A1:2014/AC:2015 표준에 대해 다룹니다. 이 표준은 의료 장비의 기본 안전과 필수 성능에 대한 일반 요구 사항을 명시합니다. 전기적 안전, 기계적 위험으로부터의 보호, 전자기 장해로 인한 위험으로부터의 보호 등의 영역을 다루고 있습니다. 이 표준은 의료 전기 장비의 안전한 사용을 보장하기 위한 것입니다.