IEC 60601-1-11 Medical Equipment Package Testing
This international standard applies to the basic package integrity of medical electrical equipment in the home healthcare environment. As an ISTA and ISO 17025 certified lab, we realize the importance of IEC 60601 testing. Meeting the IEC testing requirements can be difficult. We understand the challenges and guide companies through the process.
Keystone Compliance partners with customers to achieve package compliance. We create an accurate test plan to eliminate expensive over-testing. Our proven process helps avoid product launch delays. We have a reputation for helping customers achieve their package certifications. Lastly, Keystone provides the peace of mind that all of your needs will be met.
Request a quote to receive testing services customized to your specific needs. Have a question about medical and home health care package testing? Contact us and we will determine the best course of action.
Summary of IEC 60601-1-11 Home Health Care Testing
Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
IEC 60601-1-11 Package Sustainability Testing Introduction:
Medical practice increasingly uses medical electrical equipment and medical electrical systems for monitoring, treatment, or diagnosis of patients in the home healthcare environment. The safety of medical electrical equipment in this uncontrolled environment concerning the electrical installation and its related safety and protection means is a cause for concern.
IEC 60601-1-11 and EN 60601-1-11 testing procedures give special guidance on how this should be addressed in the instructions for use.
Within the two main categories are several sub-categories. These include mobile, portable, hand-held, and body-worn. The IEC 60601-11-1 transportation testing standard includes the following chart that displays the qualitative assessment of home healthcare medical equipment subjected to shock and vibration:
Non-Transit-Operable Use | ||||
| Mobile | Portable | Hand-Held | Body-Worn | |
| Vibration | 1 | 1 | 1 | 1 |
| Shock | 1 | 1 | 1 | 1 |
| Drop | 1 | 1 | 3 | 2 |
Transit-Operable Use | ||||
| Mobile | Portable | Hand-Held | Body-Worn | |
| Vibration | 2 | 2 | 2 | 1 |
| Shock | 2 | 2 | 3 | 2 |
| Drop | 2 | 2 | 3 | 3 |
Even the normal use of medical equipment in the home healthcare environment can be hazardous. Patients and their families, especially children, can be rough when handling equipment.
Package testing standard, IEC 60601-1-11, was developed with contributions from clinicians, engineers, and regulators.
The terminology, requirements, general recommendations, and guidance of EN 60601-1-11 are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and technical committees responsible for the development of particular standards.
Expert IEC 60601-1 Medical Equipment Laboratory Testing
We can accommodate flexible and rigid packages of all sizes, including large pallets. Keystone has a full lab of test equipment which permits us to provide short lead times on scheduling. Our team strives to give our customers more time and energy on product development instead of testing.
Request a quote and find out first hand about our competitive pricing, timely process, and outstanding reputation. Contact us to receive more information on IEC medical equipment package testing.