-50% discount* If you buy the same UNE standard in different languages. * Discount on the lower pvp.

IEC 60601-1-12:2014+AMD1:2020 CSV

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

Edition date: 2020-07-22
In Force
Available languages: English, French
Summary: IEC 60601-1-12:2014+A1:2020 constitutes a collateral standard to IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the emergency medical services environment. The safety of medical electrical equipment in this uncontrolled, rough environment is a cause for concern. This collateral standard was developed with contributions from clinicians, engineers and regulators. The terminology, requirements, general recommendations and guidance of this collateral standard are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and for technical committees responsible for the development of particular standards. This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, which are intended, as indicated in the instructions for use by their manufacturer, for use in the EMS environment (Emergency Medical Services environment). The object of this collateral standard is to provide general requirements for ME equipment and ME systems carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This consolidated version consists of the first edition (2014) and its amendment 1 (2020). Therefore, no need to order amendment in addition to this publication.

L'IEC 60601-1-12:2014+A1:2020 constitue une norme collatérale de l'IEC 60601-1: Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles désignée ci-après par norme générale. La pratique médicale utilise de plus en plus des appareils électromédicaux et des systèmes électromédicaux pour la surveillance, le traitement ou le diagnostic des patients dans l'environnement des services médicaux d'urgence. La sécurité des appareils électromédicaux dans cet environnement particulièrement difficile et non contrôlé, est source de préoccupation. La présente norme collatérale a été élaborée grâce aux contributions de médecins cliniciens, d'ingénieurs et d'autorités de tutelle. La terminologie, les exigences, les recommandations générales et les lignes directrices contenues dans la présente norme collatérale ont pour objectif d'être utiles aux fabricants d'appareils électromédicaux et de systèmes électromédicaux et aux comités techniques responsables de l'élaboration des normes particulières. La présente Norme internationale s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux et des systèmes électromédicaux, désignés ci-après par appareils EM et systèmes EM, destinés, comme indiqué dans les instructions d'utilisation, par leur fabricant à être utilisés dans l'environnement SMU (environnement des Services Médicaux d'Urgence). L'objet de la présente norme collatérale est de fournir des exigences générales pour les appareils EM et les systèmes EM acheminés et utilisés sur les lieux d'une intervention en urgence, ainsi que pour leur transport, dans des situations où les conditions ambiantes sont différentes des conditions intérieures. La présente norme collatérale est destinée à spécifier des exigences générales qui viennent s'ajouter à celles de la norme générale et à servir de base pour les normes particulières. Cette version consolidée comprend la première édition (2014) et son amendement 1 (2020). Il n'est donc pas nécessaire de commander l'amendement avec cette publication.
ICS: 11.040.01-Medical equipment in general
CTN: TC 62/SC 62A - 1359

Modificaciones Normas

Es modificada por IEC 60601-1-12:2014/AMD1:2020

Otras Relaciones

Acuerdo de Frankfurt FprEN 60601-1-12:2014

The book in the author's words

Ultricies magna feugiat malesuada sociosqu varius vivamus cubilia parturient, himenaeos vitae vehicula nam placerat netus urna platea, nostra rutrum felis mattis penatibus velit quisque.

Button
Frequently Asked Questions Do you have any questions about our products?
  • Standards UNE, EN, ISO, IEC, BSI, DIN, ASTM, AFNOR, IEEE, SAE
  • In addition, you can request the rules of the rest of the organizations through the e-mail normas@aenor.com
  • Technical books on paper and in electronic format (PDF, epub).

The standards can be purchased in PDF, reading or paper. The reading standards are not download files, they can only be viewed in the client area. The standards ordered on paper and some of the books in the catalogue are printed on demand. 

Check deadlines in normas@aenor.com.

The license of use is for one user and one device, if you want to reproduce the content of the standard, you must request a license that will have an additional cost. Send us your inquiry here 

The AENOR standards and books that appear in the online store can only be purchased exclusively through the website. AENOR does not have a physical store.

Purchase procedure: by clicking on "Buy" the desired products will go to the shopping cart. If there are display problems, the recommended browser is Chrome.

To formalize the purchase you must access the customer area. If you are not registered as a customer, you must fill in a form with the data along with a password and username. This will create the account.

Once the "Customer data" form has been completed, "Order in progress" will be displayed with all the items loaded in the shopping cart, their prices, taxes established in current legislation and shipping costs if applicable.

The prices of the standards and books that appear in the various sections do not include taxes or shipping costs.

AENOR promotional codes consist of alphanumeric characters and can only be applied to online purchases, received through a specific offer and for a limited time. To apply your promotional code, you just have to enter it in step 2 of 4 of the purchase process on the website and click on "apply", after you have identified yourself and chosen the payment methods. Promo codes are not cumulative.

 

  • Credit or debit card (Visa, Mastercard) and PayPal.
  • Bank transfer. If you opt for this form of payment, you must first send AENOR a copy of the transfer by email to normas@aenor.com
  • The purchase invoice can be downloaded from the customer area, in my previous orders

In the case of clients of companies based abroad, the taxpayer identification number of the corresponding country (for example, in Argentina the CUIT), must be filled in the CIF/NIF - VAT field .

  • Direct download via the website in the Customer Area. In the customer area, which can only be accessed with a password and username, the products purchased will be available for a period of fifteen days from the date of purchase, as long as the payment has been accepted. Files in digital format are protected and in no case editable. Before purchasing them, it is important that the license of use is read and accepted as a prior step to purchase.
  • Shipping by courier. Products purchased on physical media are shipped by courier. The maximum delivery time in Spanish territory, from the acceptance of the order by AENOR, is:
  •  Approximately seven working days for all standards purchased through the store in paper format.
  • Approximately three days for books purchased through the store. Stocks of paper books are limited and their offer on the website does not imply availability within the indicated period. In the event that the requested book is not available, the customer is notified of the delay in receiving the order, which will be approximately seven working days. 

For the rest of the products that are not on the website, check availability and delivery time at normas@aenor.com.

1. For digital products (PDF, Epub), once delivery has been made by direct download via the website in the Customer Area, you will not have the right to exercise your right of withdrawal.

2. For personalised products on paper, once the purchase has been made, you will not have the right to exercise your right of withdrawal.

3.  For all other paper products, you have the right to withdraw from the sale within 14 calendar days from the date of purchase. Remember that for the return it is essential that the product is in perfect condition, sealed by the packaging and preserving its original packaging. The customer will be responsible for pickup and shipping costs.

The order invoice includes shipping costs, so there is no amount to pay to the courier. Shipping costs are calculated based on both the final destination of the order and the number of products ordered. They include transport and packaging costs. Shipping costs are subject to periodic revisions. Outlet books will have free shipping costs only if the shipment is made in the Peninsula.

Destination Up to three standards and/or publications From three standards and/or publications
Peninsula 7,31€ 8,60€
Balearic Islands 18,04€ 23,34€
Canary Islands, Ceuta and Melilla  18,04€ 23,34€
Europe 59,17€ 80,07€
United States and Canada 70,07€ 96,94€
Rest of the world 91,94€ 115,91€
  • Purchases made by residents of the Member States of the European Union will be subject to the payment of VAT (value added tax).
  • ​​
  • In the case of legal persons and natural persons who, acting as entrepreneurs, are domiciled in a Member State of the European Union (except residents in Spain) and have an intra-community NIF/VAT registered in the VIES census, they will be exempt from paying VAT, being an essential condition the sending of this document by email to normas@aenor.com.
  • Purchases made in a private capacity (natural person), regardless of where they have their residence, will be subject to the payment of VAT.
  • Purchases made by entities in non-EU countries will be exempt from paying VAT, as long as they send the corresponding tax residence document by email to normas@aenor.com.
  • The sale operations will be understood to have been carried out at AENOR's registered office: Génova 6, 28004, Madrid – Spain. 

The contract for the purchase of products through this Website shall be governed by Spanish law. Any dispute arising out of or in connection with the use of the Website or such contract shall be subject to the exclusive jurisdiction of the Courts and Tribunals of Madrid.

Notwithstanding the foregoing, if you are entering into this contract as a consumer under the terms of Royal Decree 1/2007, nothing in this clause shall affect the rights that may be granted to you as such under applicable law.