IEC 60601-1-11 Package Testing
This international standard applies to the basic safety 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 home health care requirements can be difficult. We understand the challenges and guide companies through the process.
Keystone Package Testing partners with customers to achieve package compliance. When packages do not meet the requirements, we assist with finding solutions. We are in constant communication throughout the test process. We provide comprehensive reports shortly after the completion of the integrity compliance testing.
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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 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 with regard to the electrical installation and its related safety and protection means is a cause for concern.
The potential lack of training of the operator and possibly of those supervising the use of the medical electrical equipment or medical electrical system and their level of education need to be addressed in the development of the accompanying documents and in the relevant marking on the equipment itself so that this material can be understood.
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 package integrity 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.
To address these conditions, test methods have been designed based on the medical devices use categories. The IEC 60601-1-11 test standard assigned categories to devices. These categories are based on whether the equipment is designed to be stationary or moved during normal use.
IEC 60601-11-1 transit testing states provide a grey area in determining product failures. For instance, during testing, temporary interruptions of intended operation can be tolerated if consistent with essential performance.
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 for technical committees responsible for the development of particular standards.
Expert IEC 60601-1 Medical Equipment Transit Compliance Testing
Keystone Package Testing assists manufacturers with IEC 60601-1-11 and EN 60601-1-11 test compliance. Also, we have 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.
Please contact us for more information on how Keystone Package Testing can assist you with identifying and fulfilling your IEC 60601-1-11 test lab needs. For more information on medical package testing, please follow the link: KeystonePackage.com – Industries – Medical Devices
Interested in the EMC/EMI, climatic, dynamic, shielding effectiveness, or IP Code testing of a product? Follow the corresponding links or www.keystonecompliance.com for more information.