CORRECT APPLICATION DIN EN 62368-1 TO HAZARD BASED SAFETY ENGINEERING
- The easyCE-Delta-Comparison allows you to secure your existing products (AV and ICT) that have already been tested and certified according to DIN EN 60950-1 or DIN EN 60065-1 with an update to the latest safety standards according to DIN EN 62368-1.
- Highest safety standards: reliable and uncomplicated.
You simply apply the CE mark and sign the Declaration of Conformity, worry-free
Willy Lebherz
Director & founder of easyCE GmbH
Declaration of conformity done!
Receive your CE declaration of conformity ready for signature.
Risk assessment completed!
CE mandatory risk analysis conducted.
Relevant directives & standards applied!
Your product evaluated against relevant directives and standards.
Technical documentation created!
Receive a pragmatic, user-friendly operating manual.
CE mark attached!
Simply affix the CE mark and you're done.
FAQ
Was DIN EN 62368-1 related to HBSE? (Hazard-based safety engineering)
Product safety redefined: The DIN EN 62368-1 standard sets new safety standards with the HBSE concept. With the danger-oriented approach, the standard focuses on the connection between sources of danger and their impact on the body.
When will the standard be used and which products will be affected?
The future of product safety based on DIN EN 62368-1 will apply from 20 December 2020. This applies to multimedia products that were previously covered by DIN EN 60065 (audio/video devices) and DIN EN 60950-1 (information and communication technology).
Which hazards are taken into account?
The hazard-based approach (HBSE) takes into account damage (to humans, animals and objects) resulting from energy sources of sufficient strength and duration. These include: electrical, mechanical and thermal energy sources, as well as beam sources and chemical hazards. The energy sources are divided into 3 classes depending on their severity.
Do existing products have to be re-evaluated and certified?
All multimedia products that are placed on the market after 20 December 2020 or want to obtain product approval must be certified according to DIN EN 62368-1. The use of the new standard is also mandatory for CE certification. Older products that have already been tested by the previous standards (AV or ICT) remain valid.
What are the obligations for the manufacturer?
All manufacturers and developers of multimedia devices are obliged to apply the new standard DIN EN 62368-1 and implement the safety standards for their products.
A new approval with testing according to current safety standards is also required for every product change (on existing products). The manufacturer thus proves that known hazards have been taken into account and that the product can be used safely within its limits.
What support can manufacturers expect from easyCE?
easyCE supports manufacturers in the entire testing and certification process of products according to the applicable standards. The products are always checked by our experts for the latest safety standards. easyCE offers customized solutions for certification, both for new products and for product changes of any kind.
With the easyCE Delta Comparison, manufacturers can have their existing products (AV and ICT) that have already been tested and certified according to DIN EN 60950-1 or DIN EN 60065-1 secured with an update to the latest safety standards according to DIN EN 62368-1. Highest safety standards: reliable and uncomplicated
Hundreds of companies trust easyCE
With easyCE, product compliance is really 'easy'
Approach to CE marking
Type and manner of support
Scope of support
Contact during project processing
Find the easiest way to obtain the CE mark
Abbreviated process for CE derived directly from CE
All-inclusive or modular – whatever you prefer
Personal contact with experts who take your wishes into account
other CE service providers
Often lacking in sound judgement and unnecessarily complicated
Mostly flexible but often bureaucratic
Mostly flexible in terms of support scope
Mostly personal contact
CE Software
Follows standardised process; special circumstances not taken into account
Double burden for you: software management + no support during processing
Only according to software scope and purchased modules
No contact
You want support that lightens your workload and doesn't create more work.
Reference Projects
CE marking of laboratory machines developed in-house
In the course of an upcoming ISO 45001 occupational health and safety audit, easyCE supported a laboratory technology manufacturer in ensuring CE conformity for its internally used validation machines for medical equipment. Our specialists conducted a comprehensive assessment of occupational health and safety aspects and integrated these into the CE documentation. Particular attention was paid to safe operation by laboratory staff and the documentation of risk assessments that meet both CE and ISO 45001 requirements.
Takes into account, among others: 2006/42/EU, 2014/35/EU, 2014/30/EU, 2011/65/EU EN ISO 12100, EN 60204-1
CE marking for a laboratory robot
In the course of an upcoming ISO 45001 occupational health and safety audit, easyCE supported a medical technology manufacturer in achieving CE conformity for its coagulation robot—a specialized laboratory machine for the automated performance of coagulation cycles for testing purposes. Our specialists conducted a comprehensive assessment of occupational health and safety aspects and integrated these into the CE documentation. Particular attention was paid to the safe handling of electrosurgical components and the documentation of risk assessments that meet both CE and ISO 45001 requirements.
Takes into account, among others: 2006/42/EU, 2014/35/EU, 2014/30/EU, 2011/65/EU, EN ISO 12100, EN 60204-1, etc.
CE marking and consulting for laboratory equipment
In the context of an upcoming ISO 45001 certification, easyCE supported a medical technology manufacturer with the CE documentation for a specialized testing and calibration machine for insufflators in the laboratory sector. Our specialists developed integrated documentation that covers both the CE requirements and the occupational health and safety aspects according to ISO 45001. Particular attention was paid to the safety requirements for handling various hose systems and connections, which can vary depending on the insufflator model.
Takes into account, among others: 2006/42/EU, 2014/35/EU, 2014/30/EU, 2011/65/EU, EN ISO 12100, EN 60204-1 etc.
CE marking for electrical equipment in medical laboratories
As part of the ISO 45001 certification preparation process, easyCE supported a manufacturer of electrical laboratory equipment in the correct classification and CE conformity of its products. Our experts carried out a precise analysis to distinguish between medical devices and electrical equipment in order to ensure correct classification in terms of occupational health and safety. This clarity was crucial for the ISO 45001 requirements regarding hazard identification and risk assessment in the workplace. Successful documentation and conformity assessment enabled the customer to operate its laboratory equipment in full compliance with occupational health and safety guidelines and to pass the ISO audit without any objections.
Takes into account, among others: EN 55032, EN 55035, EN 60335-1 etc.
CE marking for test station for low-pressure units
In the run-up to an ISO 45001 occupational health and safety audit, easyCE supported an industrial company in compiling CE documentation for an internal test bench for low-pressure units in accordance with occupational health and safety regulations. Our experts first analyzed the regulatory classification of the test bench and were able to prove through precise measurements that the Pressure Equipment Directive was not applicable. This clarification was crucial for the correct risk assessment within the framework of the ISO 45001 management system. The CE documentation subsequently created took particular account of occupational health and safety aspects such as operational safety and emergency procedures. This enabled the customer not only to demonstrate CE conformity, but also to pass its ISO 45001 certification without any deviations in the area of work equipment.
Takes into account, among others: 2006/42/EG, EN ISO 12100, EN 60204-1, EN ISO 4414, EN ISO 13849-1 etc.
Learn more about our project references and success stories
Get CE-marking done in 3 simple steps
Step 1
Request expert opinion
Ask for our expert opinion free of charge and find out what is necessary for the CE marking of your product. Be prepared to describe your product in broad terms.
Step 2
Receive our offer
If your product is subject to CE marking, we offer you our support with the CE marking and all accompanying measures. We will be happy to explain necessary steps on the phone.
Step 3
We get it done
When you place an order, you will be assigned your own personal CE expert who will carry out your CE marking and accompany you throughout the entire process. Your expert will also be at your side after the CE marking has been successfully completed.
Get CE-marking done, worry-free
Trust the experts of product safety and conformity
Willy Lebherz - Founder and Managing Director of easyCE
- Expert in product safety and conformity since 1995
- Recipient of the "Medal of the Order of Merit of the Federal Republic of Germany", awarded in 1983 by the then Federal President Carl Carstens
- Master of measurement and control technology
- Captain (ret.), Project Officer for Technical Logistics in the Army Material Office and Chief of the Telecommunications Repair Company
easyCE is a digital, dynamic engineering office with a focus on product safety and product conformity - especially CE-marking. We support manufacturers, operators and dealers in designing products safely and offering them on the market in compliance. We are a "full-service provider" and can take over the entire conformity assessment process for you if you wish. To do this, we support you in carrying out risk assessments, researching standards, product analyses, developing suitable safety precautions, preparing user-friendly technical documentation, coordinating tests and all other accompanying measures. easyCE was founded in southern Germany, but is now active globally.
We know what you need to do to get CE-marking done, worry-free.